Atlas FDA

GCJ

1,426 FDA 510(k) clearances · Product code

88 daysmedian time to decision
245 days90th percentile
1,426clearances measured

FDA profile

Official device name
Laparoscope, General & Plastic Surgery
Device class
Class II (moderate risk)
Regulation
21 CFR 876.1500
Medical specialty
Gastroenterology, Urology
FDA definition
Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
Adverse events (MAUDE)
2021: 3,431 · 2022: 3,945 · 2023: 6,002 · 2024: 6,047 · 2025: 5,936 · 2026: 4,241
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Sort:Newest firstOldest first

Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
EZ-Close™ (EZ Close Port Site Closing Device, EZ Close MAX Port Site Closing Device, EZ Close II Port Site Closing Device) (K253541)Medical Impact2026-07-24
LED LCD Monitor (OEV-271H) (K261614)Lg Electronics.Inc2026-07-17
Universal Seal (5-12 mm) (K261249)Intuitive Surgical, Inc.2026-07-14
FloShield Air System (FSS-01-1000T - 10mm, 0 Degree FloShield Air, FSS-02-1030T - 10mm, 30 Degree FloShield Air, FSS-03-1045T - 10mm, 45 Degree FloShield Air, FSS-01-0500T - 5mm, 0 Degree FloShield Air, FSS-02-0530T - 5mm, 30 Degree FloShield Air, FSS-01-0545T - 5mm, 45 Degree FloShield Air) (K260710)FloShield, Inc.2026-06-11
“Tech-Image” Video Endoscope System (K260414)Tech-Image CO., LTD.2026-06-10
TroKit Laparoscope Lens Wiper (K253994)TroCare, LLC2026-06-04
Inno-Port Disposable Bladed Trocar (K252532)Taiwan Surgical Corporation2026-06-02
4K NIR/ICG Imaging System (K260318)Zhejiang Healnoc Technology Co., Ltd.2026-05-26
MediBot Needle Driver Uno (K260183)Parallel Robotics, LLC2026-05-24
Laport (K252985)Sejong Medical Co., Ltd.2026-05-19
KARL STORZ Trocars with Valve Seals (K254228)Karl Storz SE & CO. KG2026-05-11
4K UHD Endoscopy Camera System (KMS-4K-2088, KMS-4K-2188, KMS-4K-2288) (K252858)Kms Medical Technology Co., Ltd.2026-04-30
Shogun Axis™ Fascial Closure System (1018S, 1018B, 1218S, 1218B, 1518S, 1518B) (K260197)Suzhou Shenyun Medical Equipment Co., Ltd.2026-04-08
TL-10 Laparoscopic Scope Cleaner (K260089)Scopix , Ltd.2026-04-08
C-Lant Port (K252714)Vigor Medical Technologies , Ltd.2026-02-27
Universal Seal (5-12 mm) (K253978)Intuitive Surgical, Inc.2026-02-24
1688 4K Camera System with Advanced Imaging Modality; 1788 4K Camera System with Advanced Imaging Modality (K260185)Stryker Endoscopy2026-02-18
Saberscope™ Laparoscope (SAS-A-536L); Xenocor® Video Processing Unit (VPUX-1) (K260177)Xenocor, Inc.2026-02-12
Medical Shaver System (Morcellator) (YSB-IIIA) (K251923)Hangzhou Hawk Optical Electronic Instruments Co., Ltd.2026-01-29
Pneumo Dissector Hook (K252957)Ab Medica Sas2026-01-23
Connected OR Hub with Device and Voice Control; SDC4K Information Management System with Device and Voice Control (K254014)Stryker Endoscopy2026-01-13
KARL STORZ Cholangiography Set (K250927)Karl Storz SE & CO. KG2025-11-22
Nuvis® Wireless HD Camera System (Nuvis-2K) (K242606)Integrated Endoscopy, Inc.2025-11-20
Kii Structural Balloon Access System (K252442)Applied Medical Resources Corp.2025-10-31
3D Laparoscope (K252697)Guangdong Optomedic Technologies, Inc.2025-10-29
VereSee Optical Veres Needle and Endoscopic Camera (K252640)Freyja Healthcare, LLC2025-10-20
Arthrex Synergy Vision Imaging System (K251994)Arthrex, Inc.2025-10-16
Revolve Surgical System (K243968)Revolve Surgical, Inc.2025-10-03
4K Endoscopic Camera System (SV-800, SV-800I, SV-800R, SV-800N) (K250551)Shenzhen Sophway Technology Co., Ltd.2025-10-02
SPI LaproSac™ Laparoscopic Single-Use Rip-Stop Nylon Specimen Retrieval System (K251743)Surgical Principals, Inc.2025-09-22
Viction Disposable Irrigation and suction System (VC-FLA0514; VC-FLA0523; VC-FLA0532; VC-FLB0514; VC-FLB0523; VC-FLB0532; VC-FLC0514; VC-FLC0523; VC-FLC0532; VC-FLD0514; VC-FLD0523; VC-FLD0532) (K250130)Hangzhou Viction Medical Technology Co.,Ltd2025-08-06
Viction Disposable Irrigation and suction catheter (VC-IRA0532, VC-IRA0523, VC-IRB0532, VC-IRB0523, VC-IRC0532, VC-IRC0523, VC-IRD0532, VC-IRD0532) (K250124)Hangzhou Viction Medical Technology Co.,Ltd2025-08-06
SPY Laparoscope (K252010)Stryker Endoscopy2025-07-24
Disposable Trocars (K250820)Sinolinks Medical Innovation, Inc.2025-07-11
8 mm Assist Cannula; 12 mm Assist Cannula (K251490)Intuitive Surgical, Inc.2025-07-02
Boehringer Laboratories Liver Retractor (K243399)Boehringer Laboratories, LLC2025-07-02
Medical Monitor (32HS710S) (K251209)Lg Electronics.Inc2025-06-12
Arthrex Synergy Vision Endoscopic Imaging System (K250728)Arthrex, Inc.2025-05-05
LAGIS Suction Irrigation System (K243867)Lagis Enterprise Co., Ltd.2025-03-17
DANNIK® Laparoscopic Single-Use Poly Specimen Retrieval System (K250411)Dannik, LLC2025-03-12
Medical Monitor (27HS714S) (K243439)Lg Electronics.Inc2025-01-28
Arthrex NanoScope System (K243008)Arthrex, Inc.2025-01-22
LCD Monitor (MDEC-2523) (K243307)Barco N.V.2024-12-13
Suction Irrigation Tubing Set (K242927)Advamedix, GmbH2024-11-22
MultiCut Solo (K240831)Asclepion Laser Technologies GmbH2024-11-06
LAGIS Endoscopic Instruments - Grasper (DI-5670-33D, DI-5670-45D, DI-5716-33D, DI-5716-45D, DI-5719-33D, DI-5731-33D, DI-5731-45D, DI-5901-33D, DI-5901-45D) (K240334)Lagis Enterprise Co., Ltd.2024-10-30
FloNavi Endoscopic Fluorescence Imaging System (OPTO-CAM214K, OPTO-CHD214KE, OPTOCHD214KH, OPTO-LED214K) (K242513)Guangdong Optomedic Technologies, Inc.2024-10-23
Bladeless Trocar; Bladed Trocar; Hasson Trocar (K241052)Advamedix, GmbH2024-10-04
TroCare TroKit Laparoscope Lens Wiper (CP000626) (K241796)TroCare, LLC2024-10-04
da Vinci Handheld Camera (K241913)Intuitive Surgical Operations, Inc.2024-08-28
Connected OR Hub with Device and Voice Control; SDC4K Information Management System with Device and Voice Control (K241401)Stryker Endoscopy2024-08-15
Medical Monitor (32HR734S) (K241402)Lg Electronics.Inc2024-08-12
Stellar Imaging System (K241530)Guangdong Optomedic Technologies, Inc.2024-08-07
Universal Seal (5-12 mm) (K241360)Intuitive Surgical, Inc.2024-08-05
Arthrex Synergy Vision Endoscopic Imaging System (K241361)Arthrex, Inc.2024-07-25
P-SCOPE (K241502)Oui Medical, Inc.2024-07-24
Endoscopic Applicator, 41 cm (K241739)Micromedics, Inc.2024-07-15
AMT Suture Passer (K241111)Applied Medical Technology, Inc.2024-07-05
Endoscopic Fluorescence Camera System (DPM-ENDOCAM-03PF) (K233840)Zhuhai Dipu Medical Technology Co., Ltd.2024-06-26
SCHOELLY Oxygen Saturation Imaging (OSI) Camera System (Camera Control Unit, Camera Head to be coupled to a fiberoptic scope) (K233225)Schoelly Fiberoptic GmbH2024-06-20
Bladeless Trocar (E05, E10, E11, E12, ES05, ES10, ES12) (K240196)Yuwonmeditech Co., Ltd.2024-06-18
3D Endoscopic Fluorescence Camera System (DPM-ENDOCAM-06PF) (K233892)Zhuhai Dipu Medical Technology Co., Ltd.2024-06-13
Monik™ - Disposable Endoscopic Trocar (K233386)M/s. Meril Endo Surgery Private Limited.2024-05-24
Ez Catch Auto; Ez Catch YR; Ez Catch TR (K240205)Veol Medical Technologies Pvt , Ltd.2024-04-15
Disposable Trocars (K233263)Hangzhou Kangji Medical Instrument Co., Ltd.2024-04-09
ENDOCOLLECT Specimen Retrieval Bag, 8mm, ENDOCOLLECT Specimen Retrieval Bag, 12mm, ENDOCOLLECT Specimen Retrieval Bag, 15mm (K240635)Ximedica2024-04-01
1688 4K Camera System with Advanced Imaging Modality (K240174)Stryker Endoscopy2024-02-22
Arthrex Synergy Vision Endoscopic Imaging System (K233451)Arthrex, Inc.2024-01-18
MD Mattress Suture Placement Device (K222783)Lsi Solutions, Inc.2024-01-12
1788 4K Camera System with Advanced Imaging Modality (K233327)Stryker Endoscopy2024-01-09
ENDOCOLLECT Specimen Retrieval Bag (K232519)Ximedica2024-01-05
CuratOR EX3242-FD (K231066)Eizo Corporation2023-12-18
Disposable Abdominal Trocars (Bladed Trocars, Bladeless Trocars, Optical Trocars) (K232866)Jiangsu Channel Medical Device Co., Ltd.2023-11-07
Inzii Ripstop Redeployable Retrieval System (K232880)Applied Medical Resources Corporation2023-11-01
NexPort™ Trocar System (TS211001); NexPort™ Trocar System (TS211002); NexPort™ Trocar System (TS211003); NexPort™ Trocar System (TS211010); NexPort™ Trocar System (TS211011); NexPort™ Trocar System (TS211012); NexPort™ Trocar System (TS221001); NexPort™ Trocar System (TS221002); NexPort™ Trocar System (TS221003); NexPort™ Trocar System (TS221010); NexPort™ Trocar System (TS221011); NexPort™ Trocar System (TS221012); NexPort™ Trocar System (TS221020); NexPort™ Trocar System (TS221021); (K232042)Mediconcepts Technology (Shenzhen) Company Limited2023-10-20
Laparoscope (4KA0, 4KA0R, 4KA30, 4KA30R, 4KA45, 4KA45R) (K231725)Hunan Endoso Life Technology Co., Ltd.2023-10-16
REGER Nebulizer Irrigation Cannula (K231622)Reger Medizintechnik, GmbH2023-09-29
Guardenia (GAR-1) (K232701)Advanced Surgical Concepts2023-09-29
Connected OR Hub with Device and Voice Control, SDC4K Information Management System with Device and Voice Control (K232157)Stryker Corporation2023-08-18
Bladeless Trocar – Artemis Lap Cannula (K231400)T.A.G. Medical Products Corporation, Ltd.2023-08-04
Laparoscope (21033FA, 21033FC, 21033WA, 21033WC, 20533FA, 20533FC, 20533WA, 20533WC) (K231003)Guangdong Optomedic Technologies, Inc.2023-07-06
Universal Seal (5-12 mm) (K231358)Intuitive Surgical, Inc.2023-07-05
KOH Ultramicro Injection Cannula (26167NN); Suction a. Irrig. Cannula,L. 36cm (37360CP); Suction a. Irrig. Cannula,L. 36cm (37360SC); Suction and Irrig Cannula,l. 36cm (37560LH); Suction a. Irrig. Cannula,L. 30cm (37260LH); KOH Ultramicro Injection Needle (26167NA); Puncture Needle, LUER-lock (26178R); Suction a. Irrig. Cannula,L. 43cm (37460LH); Suction a. Irrig. Cannula,L. 36cm (37360LH); Puncture Needle, dia. 1.6 mm, 36 cm (26175R); Two-Way Stopcock (26167H); Injection Needle, LUER- (K230359)Karl Storz Endoscopy America, Inc.2023-06-23
Connected OR Hub with Device and Voice Control; SDC4K Information Management System with Device and Voice Control (K230886)Stryker Endoscopy2023-06-21
Disposable Laparoscopic Trocar (K231042)Changzhou Ankang Medical Instruments Co., Ltd.2023-06-08
HandX™ Self-Righting Needle Holder (K223718)Human Xtensions , Ltd.2023-06-05
Xpan Universal Trocar System (K223562)Xpan, Inc.2023-06-02
HandX™ Monopolar Scissors (K230491)Human Xtensions , Ltd.2023-05-10
Bladeless Trocar – Artemis Lap Cannula (K230058)T.A.G. Medical Products Corporation, Ltd.2023-04-28
1788 4K Camera System with Advanced Imaging Modality (K230605)Stryker2023-03-31
HOPKINS Telescopes (K223923)KARL STORZ Endoscopy-America, Inc.2023-03-30
Inno-Port Disposable Bladeless Trocar, Inno-Port Disposable Optical Trocar (K223593)Taiwan Surgical Corporation2023-03-22
Specimen Bag, model: WEP040306B, WEP010304B, WEP040304B, WEP010759B, WEP010709B, WEP010304A, WEP010759A, WEP010709A (K222828)Wickimed (Huizhou) Medical Equipment Manufacturing Co.,Ltd2023-03-20
8X-10-6XXX Camera Head (K223116)Santa Barbara Imaging Systems2023-02-28
Arthrex SynergyID Endoscopic Imaging System (K223759)Arthex, Inc.2023-02-24
1688 4K Camera Control Unit with Advanced Imaging Modality (1688010000) (K230216)Stryker2023-02-23
Camera System (Camera Control Unit, Camera Head to be coupled to a fiberoptic scope), NIR FI Light Source (K221591)Schoelly Fiberoptic GmbH2023-02-23
FloNavi Endoscopic Fluorescence Imaging System (K221861)Guangdong Optomedic Technologies, Inc.2023-02-18
Image Processing Unit, Model: OPTO-CAM104K, Camera Head, Model: OPTO-CHD104KH (K221781)Guangdong Optomedic Technologies, Inc.2023-02-02
MultiCut Solo (K213597)Asclepion Laser Technologies GmbH2023-01-18
Next →

Track GCJ automatically

Every clearance here is in the API, with alerts when new ones post.