Atlas FDA

HET

338 FDA 510(k) clearances · Product code

151 daysmedian time to decision
498 days90th percentile
338clearances measured

FDA profile

Official device name
Laparoscope, Gynecologic (And Accessories)
Device class
Class II (moderate risk)
Regulation
21 CFR 884.1720
Medical specialty
Obstetrics/Gynecology
Adverse events (MAUDE)
2021: 132 · 2022: 216 · 2023: 824 · 2024: 3,496 · 2025: 4,569 · 2026: 2,982
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
SIRIUS Endoscope System (PR-SI-1230) (K250939)Precision Robotics (Hong Kong) Limited2025-08-29
i-Cut (K243821)A.M.I. Agency For Medical Innovations GmbH2025-04-25
SIRIUS Endoscope System (K221642)Precision Robotics (Hong Kong) Limited2022-12-12
Video Endoscopy System, 3D Video Endoscopy System (K210116)Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.2021-10-13
Endoeye Flex Deflectable Videoscope Olympus LTF-S190-5 (K201832)Olympus Medical Systems Corp.2021-09-17
SurroundScope System (K210104)270surgical , Ltd.2021-07-08
TipVision Videoscope System (TipVision VideoScope 0°/30°; EleVision HD 2 Camera Control Unit (CCU)) (K201617)Schoelly Fiberoptic GmbH2021-03-12
4K UHD Camera System (K200216)Scivita Medical Technology Co., Ltd.2020-08-21
LAP-iX Suction Irrigation (K200638)Sejong Medical Co., Ltd.2020-04-03
WV1 Endoscope (K190190)270surgical , Ltd.2019-11-01
ENDOEYE HD II (WA50040A, WA50042A, WA50050A, WA50052A) (K190744)Olympus Winter & Ibe GmbH2019-08-29
Flex Robotic System and Flex Transabdominal Drive (K172796)Medrobotics Corporation2018-01-18
LAP-iX Suction Irrigation (K173111)Sejong Medical Co., Ltd.2017-11-28
LAP-Pump PP110 (K163320)W.O.M. World of Medicine GmbH2017-03-21
SPIES 3D Tip Cam, Image 1 SPIES CCU Image Connect, Image 1 SPIES CCU D-3 Link (K150525)KARL STORZ Endoscopy-America, Inc.2015-11-20
VISERA 4K UHD SYSTEM (K151011)Olympus Medical Systems Corp.2015-10-01
MORCELLEX SIGMA GENERATOR (K131656)ETHICON, Inc.2013-09-27
OLYMPUS LTF-190-10-3D, MAJ-Y0154, OLYMPUS CV-190 (K123365)Olympus Medical Systems Corp.2013-03-01
OLYMPUS LTF-S190-10, OLUMPUS OTV-S190, OLYMPUS CLV-S190 (K111425)Olympus Medical Systems Corp.2012-04-20
ENDOEYE HD II (K111788)Olympus America, Inc.2012-01-13
LINA XCISE MODEL MOR-1515 (K101458)Lina Medical Aps2011-03-11
TROKAMED MORCELLATOR (K091010)Trokamed GmbH2011-03-01
GYNCARE MORCELLEX TISSUE MORCELLATOR (K100280)ETHICON, Inc.2010-03-24
MORCE POWER PLUS AND VARIOCARVE MORCELLATOR (K080365)NOUVAG AG2009-06-29
ENDOSCOPIC CO2 REGULATION UNIT UCR (K081173)Olympus Medical Systems Corporation2008-12-23
STRYKER VIDEOSCOPE (K082451)Stryker Endoscopy2008-12-16
HD ENDOEYE LAPARO-THORACO VIDEOSCOPE OLYMPUS LTF TYPE VH (K080948)Olympus Medical Systems Corporation2008-09-26
VERESS CANNULA AND MODULAR VERESS CANNULA (K062097)PAJUNK GmbH Medizintechnologie2006-10-13
APPLIED LAPAROSCOPIC DISPOSABLE MONOPOLAR SCISSORS (K062169)Applied Medical Resources Corp.2006-08-24
G-LIX TISSUE GRASPER (K061268)Usgi Medical2006-07-31
GYNECARE MORCELLEX TISSUE MORCELLATOR, MODELS MX0100 AND MX0100R (K061050)ETHICON, Inc.2006-07-14
INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM AND ENDOSCOPIC INSTRUMENTS (K050404)Intuitive Surgical, Inc.2005-04-21
MILTEX LAPAROSCOPIC INSTRUMENTS (K043013)Miltex, Inc.2005-03-04
VEROSCOPE OPTICAL VERESS CANNULA & DILATION TUBE SYSTEM (K041321)Richard Wolf Medical Instruments Corp.2004-07-09
APPLIED LAPAROSCOPIC MONOPOLAR SCISSORS (K040295)Applied Medical Resources Corp.2004-03-12
POWERGRIP BIPOLAR COAGULATION FORCEPS, MODEL 824XXXXX (K033177)Gunter Bissinger Medizintechnik GmbH2004-03-11
COOPERSURGICAL LAPAROSCOPIC INSTRUMENTS (K021237)CooperSurgical, Inc.2003-04-10
XENON FIBEROPTIC LIGHT SOURCE, MODEL 1300 XSBP (K022384)Isolux America2002-10-18
REPROCSSED USED DISPOSABLE ENDOSCOPIC SCISSORS AND GRASPERS (K022748)Medical Device Services2002-10-09
VASOVIEW 5 HARVESTING CANNULA (K020143)Guidant Corporation, Cardiac Surgery2002-02-20
GYNECOLOGICAL LAPAROSCOPES (K003805)Global Endoscopy, Inc.2001-07-22
BALLOON CANNULA, SHORT, MODEL R65-985; BALLOON CANNULA, LONG, MODEL R65-985-1 (K010510)A & A Medical, Inc.2001-05-16
MINI FIBER ENDOSCOPES; OUTER SHEATHS; VERESS CANNULAS; VERESS CANNULAS WITH OUTER SHEATHS, SET (K003417)Richard Wolf Medical Instruments Corp.2001-04-04
TROCARS TROTEC WITH AUTOMATIC PROTECTIVE MECHANISM (K003164)Richard Wolf Medical Instruments Corp.2001-01-08
MICRO-FRANCE TROCARS AND ACCESSORIES (K993653)Xomed, Inc.2000-06-09
ENDOPATH SURESEAL REDUCER CAP (K001220)Ethicon Endo-Surgery, Inc.2000-05-16
CORTEK MINI LAPAROSCOPE (K000199)Cortek Endoscopy, Inc.2000-04-13
CO2-OP-PNEU COMPUTER, WISAP #7050C, #7050CF, #7050CMF (K992481)Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh2000-03-17
THERME-PNEU COMPUTER, WISAP #7070C, #7070CF, #7070CM, #7070CMF (K992513)Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh2000-03-17
GYNECARE LAPAROSCOPIC MORCELLATOR (K993801)ETHICON, Inc.2000-02-07
MODULAR INSTRUMENT SYSTEM FOR MINIMAL INVASIVE SURGERY (K990372)Dr. Fritz GmbH1999-10-14
MEDIFIX SINGLE AND DOUBLE PUNCTURE LAPAROSCOPES (K992480)Medifix, Inc.1999-09-23
LAP-WAVE 3000 (P07) (K990732)W.O.M. World of Medicine GmbH1999-07-23
DCI ENDOSCOPE (K990004)KARL STORZ Endoscopy-America, Inc.1999-04-02
BAHO AUTOCLAVABLE LAPAROSCOPE (K982276)Microptix Int'L, LLC1999-02-18
POWER-DRIVE, WISAP MODEL #7688PD/7688PD1 (K982515)Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh1999-01-19
AQUA PURATOR-BIOTHERM, WISAP MODEL # 1608 (K982518)Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh1999-01-14
CHRISTOUDIAS GAUZE DISSECTOR (LAPAROSCOPIC HAND INSTRUMENT) (K982428)Innervision, Inc.1998-10-09
SMITH & NEPHEW DYONICS MICROLAPAROSCOPE (K982149)Smith & Nephew, Inc.1998-09-10
KSEA ENDO TIP SYSTEM (K981130)KARL STORZ Endoscopy-America, Inc.1998-08-19
LAPARO-TENSER (K970712)L & T S.N.C. DI E. Lucini & C.1998-07-21
DEROYAL INDUSTRIES DISPOSABLE SURGICAL TROCAR/CANNULA (K974763)Deroyal Industries, Inc.1998-07-10
BISSINGER DETACHABLE BIPOLAR COAGULATION-FORCEPS (K970968)Guenter Bissinger Medizintechnik GmbH1998-05-21
KSEA PLASTIC TROCARS (K980694)KARL STORZ Endoscopy-America, Inc.1998-05-08
CO2 PNEUMO-DISSECTOR (K972647)Cook Urological, Inc.1998-04-10
LIGHTSOURCE OR ILLUMINATOR (K980166)Cuda Products Co.1998-04-01
KSEA HYDROMAT 263110-20 PRESSURE CHAMBERS AND ACCESSORIES (K972488)Karl Storz Endoscopy1998-01-22
KSEA C.C.L. VAGINAL EXTRACTOR AND ACCESSORIES (K962985)KARL STORZ Endoscopy-America, Inc.1997-12-19
MINI TROCAR SLEEVE AND TROCARS 3.5 MM, MICRO TROCAR SLEEVE AND TROCARS 2 MM, DILATATION SLEEVE AND GUIDE ROD 2 MM TO 3.M (K973737)Richard Wolf Medical Instruments Corp.1997-12-12
MVM 3.3 MM MICROENDOSCOPE (K973304)KARL STORZ Endoscopy-America, Inc.1997-12-02
VERRESCOPE, LIGHT CABLE - LIGHT SOURCE ADAPTOR (K971836)CooperSurgical, Inc.1997-11-07
GALILEO HIGH RESOLUTION MICRO COUPLER (K971896)Netoptix Corp.1997-10-10
AMR MINI-LAPAROSCOPE (K962777)Applied Medical Resources1997-08-06
VERRES NEEDLE, CANNULA FOR M820, CANNULA W/TRUMPET VALVE FOR M 820 (K971837)CooperSurgical, Inc.1997-08-06
LAPAROSCOPIC BLADDER NECK SUSPENSION KIT (K971797)Louisville Laboratories, Inc.1997-07-22
TRISTAR LP TORCAR WITH LOW PROFILE THREADED SLEEVE (K965045)Ethicon Endo-Surgery, Inc.1997-05-05
IMAGYN EXPANDABLE LAPAROSCOPIC INTRODUCER (K971255)Imagyn Medical, Inc.1997-04-21
LAPAROSCOPIC BONE ANCHORED URETHROPEXY INSTRUMENT TRAY (K963076)Louisville Laboratories, Inc.1997-04-04
CANNULA (K965121)Origin Medsystems, Inc.1997-03-20
INTERCEPTRE LAPAROSCOPIC INSTRUMENTS (K970151)Smith & Nephew, Inc.1997-03-18
IMAGYN MICROLAP AND MICRO LAP-GOLD LAPAROSCOPES (K965055)Imagyn Medical, Inc.1997-03-06
RIWO CUT-MORCELLATOR EXISTING OF KNIFE/CUTTING SLEEVE/PROTECTION SLEEVE/CLAW GRASPING FORCEPS (K970105)Richard Wolf Medical Instruments Corp.1997-03-04
S*E*M*M* SET FOR MOTO DRIVE WISAP #7689 SSM (MODIFICATION) (K960640)Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh1997-02-14
RIGID FIBER OPTIC LAPAROSCOPE (K962246)Health Care International Assoc.1997-02-07
WESTERN SURGICAL REUSABLE LAPAROSCOPIC TROCAR SYSTEM (K964436)Western Surgical Instrument Co.1997-01-30
KSEA PUNCTURE CANNULA (K964379)KARL STORZ Endoscopy-America, Inc.1997-01-29
FEMRX MORCELLATOR SYSTEM (K963872)Gynecare Innovation Center1997-01-17
SECONDARY TROCAR AND SLEEVE WITH INSUFFLATION PORT (K964450)Pilling Weck Group1997-01-10
KSEA UNIMAT PLUS (K963960)KARL STORZ Endoscopy-America, Inc.1996-12-20
KSEA UNIMAT PLUS (K963949)KARL STORZ Endoscopy-America, Inc.1996-12-19
PYRAMID TROCAR, 10MM W/SPRING RET. PROTECTIVE SLEEVE OR TROCAR W/SPRING LOADED PROTECTION SLEEVE (K960299)Richard Wolf Medical Instruments Corp.1996-10-28
BALLOON CANNULA 15MM X 35MM,15MM X 55MM, 10/12MM X 55MM,10/12MM X 35MM,5MM X 35MM,2MM X 35MM (K960810)Marlo Surgical Technology1996-10-21
KARL STORZ MODEL 203210 O1 UNIMAT PLUS (K962090)KARL STORZ Endoscopy-America, Inc.1996-09-30
INSUFFLATION NEEDLE (K963359)Applied Medical Resources1996-09-24
A4907 LENS CLEANING SHEATH (K961860)Olympus America, Inc.1996-08-29
RDP-2 (K961922)Ranfac, Corp.1996-08-09
RESPOSABLE TROCAR SYSTEM [5MM, 5MM SHORT, 10MM AND 12MM SIZES] (K960936)Origin Medsystems, Inc.1996-07-24
SAFETY TROCER WITH SPRINGLOADED OBDURATOR (K960347)Spiess Design, Inc.1996-07-01
SHIELDED TROCAR (OBTURATOR) (K954774)Gabris Surgical Corp.1996-06-07
KARL STORZ RIGID TELESCOPES FOR OBSTERICS AND GYNECOLOGY (K950335)KARL STORZ Endoscopy-America, Inc.1996-05-16
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