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HRX

681 FDA 510(k) clearances · Product code

89 daysmedian time to decision
272 days90th percentile
681clearances measured

FDA profile

Official device name
Arthroscope
Device class
Class II (moderate risk)
Regulation
21 CFR 888.1100
Medical specialty
Orthopedic
Flags
Third-party review eligible
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: 1,908 · 2022: 1,406 · 2023: 1,852 · 2024: 2,427 · 2025: 2,105 · 2026: 1,140
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
Digital ClarusScope System and Digital NeuroPEN System (K252790)Clarus Medical, LLC2026-05-26
Freedom DS™ Decompression System (K253523)Spinal Simplicity2026-04-16
VantageTM Lumbar Decompression Kit (K252546)Allevion Medical, LLC2026-03-12
MiiS Horus Arthroscope (EJA 100); MiiS Horus Endoscope Display System -Tablet (EDS 500); MiiS Horus Endoscope Display System -Video Box (EVS 700) (K253217)Medimaging Integrated Solution, Inc (Miis)2025-12-23
PUREVUE™ FMS (K250795)W.O.M. World of Medicine GmbH2025-12-05
Articulator Arthroscopic Bur (K252666)Joint Preservation Innovations, LLC2025-11-21
Kyphoplasty Balloon Dilatation Catheters (K252458)Shanghai Lange Medtech Co., Ltd.2025-11-03
TunnelVision Endoscopic Soft Tissue Release System and the HBL Blade Assembly (K252020)Hand Biomechanics Lab, Inc.2025-10-15
UltraGuideCTR® image guided soft tissue release system (K252594)Sonex Health2025-09-29
ELID (Endoscopic Less Invasive Decompression) System (K243774)Lesspine Innovations2025-08-27
SpineSite Endoscope System (K241990)Hydrocision, Inc.2025-07-30
Arthrex Spine Endoscope (K243602)Arthrex, Inc.2025-05-16
VECTR – Video Endoscopic Carpal Tunnel Release System (K242417)Rafael Medical Devices, LLC2024-12-11
MIDASVu (K243020)Intravu, Inc.2024-12-02
Vertos mild Device Kit (MDK-0002) (K233800)Vertos Medical, Inc.2024-05-06
Digital ClarusScope System; Digital NeuroPEN System (K240535)Clarus Medical, LLC2024-04-25
FMS VUE™ Fluid Management and Tissue Debridement System (K233675)DePuy Mitek, Inc.2024-02-26
Hawkeye Control Unit with Eyas Endoscope (K233115)E Surgical, LLC2024-02-06
Kyphoplasty Balloon Catheter (K223709)Jiangsu Changmei Medtech Co., Ltd.2023-08-16
Kyphoplasty Balloon System (K221142)OK Medinet Korea Co., Ltd.2023-04-21
DOUBLEFLO INFLOW/OUTFLOW PUMP, accessories and tubing sets (K221919)Hemodia Sas2023-03-09
SmartRelease Endoscopic Soft Tissue Release System (K223406)Microaire Surgical Instruments2023-02-02
Pristine Arthroscopic Visualization System (K223244)Pristine Surgical2022-12-21
HBL Blade Assembly (K222490)Hand Biomechanics Lab, Inc.2022-11-14
TELIGEN System (K213978)Medos International SARL2022-10-18
CORUS Spinal System-X (K212636)Providence Medical Technology, Inc.2021-10-15
mi-eye 3 needlescope with cannula, mi-tablet 3 (K212556)Trice Medical, Inc.2021-09-15
SMARTRELEASE Endoscopic Soft Tissue Release System (K211297)Microaire Surgical Instruments2021-06-24
DOUBLEFLO system (K203480)Hemodia Sas2021-04-05
Balex bone Expander System (K202027)Taeyeon Medical Co., Ltd.2021-02-03
EBERLE Shaver System C3 and Accessories (K193608)Eberle GmbH & Co. KG2021-01-15
C Scope Visualization System (K203526)Cit Ortho2021-01-12
Resascope RS-01/B (K201113)Advanced Medical Systems Group Srl2020-12-21
Stryker Arthroscope (K202659)Stryker2020-12-01
Zeos Aqua Vision Pump and tube (K192921)Hemodia Sas2020-10-09
MectaScope System (K200067)Medacta International S.A.2020-10-01
Osteo-site Vertebral Balloon (K200763)Izi Medical2020-08-12
Smith+Nephew Arthroscopes (K201349)Smith & Nephew2020-07-20
HydroCision SpineJet System (K200729)Hydrocision, Inc.2020-04-16
Arcadia Balloon Catheter (K191596)Merit Medical Systems, Inc.2019-10-09
Smith & Nephew DYONICS 25 Fluid Management System (K192155)Smith & Nephew, Inc.2019-09-04
Pegasus System (K191345)A.M. Surgical, Inc.2019-07-17
Stryker CrossFlow Integrated Arthroscopy Pump (K191259)Stryker Corp.2019-07-12
Nuvis Battery Arthroscope (K191594)Integrated Endoscopy, Inc.2019-07-11
Voyant System (K191579)Viseon, Inc.2019-07-11
HydroCision TenJet Device (K190804)Hydrocision, Inc.2019-06-05
MEDINAUT Plus (K182287)Imedicom Co., Ltd.2019-04-06
CROSSWAY Spinal Access System (K190598)Globus Medical, Inc.2019-04-05
CORUS Spinal System (K190201)Providence Medical Technology, Inc.2019-03-08
Pristine Scope (K183165)Pristine Surgical2019-01-16
Precision Ideal Eyes Arthroscopes (K183470)Stryker2019-01-07
Stryker iVAS Elite Inflatable Vertebral Augmentation System (Stryker iVAS Elite Balloon Catheter) (K181752)Stryker Corporation2018-12-21
CrystalView Pro Irrigation Console, CrystalView Pro Autoclavable Remote Control (K182882)Conmed Corporation2018-11-14
SMARTRELEASE Endoscopic Soft Tissue Release System (K181819)Microaire Surgical Instruments, LLC2018-11-06
Voyant System (K181885)Viseon, Inc.2018-10-02
MIDAScope and Introducer Kit, and MIDASystem (K181982)Intravu, Inc.2018-08-21
Endiscope, Endiscope Cervical (K180766)Elliquence, LLC2018-06-11
Single Use Arthroscopic Electrode (with Pencil) (K170703)Modern Medical Equipment Manufacturing Limited2018-05-31
DTRAX Spinal System (K180876)Providence Medical Technology, Inc.2018-05-18
ARTHRO-Pump PA304 (K173311)W.O.M. World of Medicine GmbH2018-05-09
DISKOM (K180315)Biopsybell S.R.L.2018-03-26
Stryker iVAS Elite Inflatable Vertebral Augmentation System (Stryker iVAS Elite Balloon Catheter) (K172116)Stryker Corporation2018-01-25
FMS VUE II Fluid Management and Tissue Debridement System (K171237)Medos International SARL2018-01-18
Reprocessed Shavers/Burs (K172092)Renovo, Inc.2017-10-04
Smith & Nephew 25 Fluid Management System (K171794)Smith & Nephew, Inc.2017-06-27
JOINIX CANNULAR SYSTEM (K162070)Aju Pharm Co., Ltd.2017-03-16
Intra medullary endo-transilluminating device (iMET device) (K163037)WeMED Bio-Tech, Inc.2017-02-17
AVAmax Vertebral Balloon, AVAflex Vertebral Balloon (K162062)Stryker Corporation2016-11-01
PORTAGE System (K161878)Baylis Medical Company, Inc.2016-09-26
mi-eye 2, mi-eye 2 monitor (K162475)Trice Medical2016-09-16
Neo - Arthroscope (Rigid) 2.0mm/3.5mm, Outer sheath/ cannula, Outer sheath/ cannula w/ Handle, Trocar for outersheath/ cannula (K152511)Prosurg, Inc.2016-07-11
ULTRA Telescopes (K160249)Olympus Winter & Ibe GmbH2016-04-21
Stryker CrossFlow Day-Use Inflow Cassette Tubing and Patient-Use Tubing (K151932)Stryker Corporation2016-03-31
SPINAUT-V, SPINAUT-S, SPINAUT-I (K151268)Imedicom Co., Ltd.2016-03-16
VS3 STEREOSCOPIC HIGH DEFINITION VISION SYSTEM (K153548)Visionsense, Ltd.2016-02-22
AVAflex Vertebral Balloon System (K151125)Care Fusion2015-11-24
AVAmax Vertebral Balloon (K150523)Care Fusion2015-10-29
KYPHON ELEMENT Inflatable Bone Tamp (K151532)Medtronic, Inc.2015-07-23
NeedleCam HD Visualization System (K143705)Biovision Technologies, LLC2015-02-20
HERNIATOME PERCUTANEOUS DISECTOMY DEVICE - CERVICAL, HERNIATOME PERCUTANEOUS DISECTOMY DEVICE - LUMBAR (K141557)Gallini Medical Devices, Srl2014-12-08
NEEDLE VIEW CH SCOPE KITS (K141326)Biovision Technologies, LLC2014-10-08
CAMERA ENABLED PROBE (K141119)Trice Medical, Inc.2014-07-29
NUVIS ARTHROSCOPE (K140903)Integrated Endoscopy, Inc.2014-07-17
VS3 STEREOSCOPIC HIGH DEFINITION VISION SYSTEM (K141002)Visionsense, Ltd.2014-06-26
SCHOELLY ARTHROSCOPE (K133682)Scholly Fiberoptic GmbH2014-06-02
MITEK ARTHROSCOPES (K133941)Medos International SARL2014-04-18
DISCOSCOPES, CERVICAL ENDOSCOPES (K130778)Rz Medizintechnik GmbH2014-04-14
OSI Q SYSTEM ARTHROSCOPES (K133018)Orthopedic Sciences, Inc.2014-02-26
ESPIN SYSTEM (K133061)Nlt Spine, Ltd.2013-11-27
HEMODIA ARTHROSCOPY PUMP TUBE SETS (HATS) (K132883)Hemodia Sas2013-11-01
AVAMAX VERTEBRAL BALLOON SYSTEM, 8G, AVAMAX VERTEBRAL BALLOON SYSTEM, 10G, AVAMAX VERTEBRAL BALLOON SYSTEM, 11G (K131820)Care Fusion2013-10-04
AVAFLEX VERTEBRAL BALLOON SYSTEM (K131824)Care Fusion2013-10-03
4MM & 5MM FULL RADIUS BLADE PLUS, 4MM & 5MM BARREL BUR PLUS/4MM BARREL TORNADO BUR PLUS, 4MM & 5MM AGGRESSIVE BLADE PLUS (K131191)Depuy Mitek, A Johnson & Johnson Company2013-07-22
OMNICUT RESECTION BLADE (K130912)Depuy Mitek, A Johnson & Johnson Company2013-06-14
IVAS 10MM AND 15MM BALLOON CATHETER (K130430)Stryker Corporation2013-05-23
FMS VUE FLUID MANAGMENT SYSTEM, FMS CONNECT INTERFACE CABLE (K130169)Depuy Mitek, A Johnson & Johnson Company2013-05-01
J-SCOPE SYSTEM (K122411)Myelotec2013-02-11
ESPIN (K130057)Nlt Spine, Ltd.2013-02-07
STRYKER CROSSFLOW ARTHROSCOPY PUMP (K123441)Stryker Endoscopy2013-01-09
ASAP MUITISCOPE (K121261)Asap Endoscopic Products GmbH2013-01-08
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