HRX · Arthroscope
Orthopedic · 21 CFR 888.1100 · Class 2
Overview
| Product Code | HRX |
|---|---|
| Device Name | Arthroscope |
| Regulation | 21 CFR 888.1100 |
| Device Class | Class 2 |
| Review Panel | Orthopedic |
| 3rd-Party Reviewable | Yes |
Identification
An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint.
Classification Rationale
(1) Class II (performance standards).(2) Class I for the following manual arthroscopic instruments: cannulas, currettes, drill guides, forceps, gouges, graspers, knives, obturators, osteotomes, probes, punches, rasps, retractors, rongeurs, suture passers, suture knotpushers, suture punches, switching rods, and trocars. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9.
Cleared Devices (680)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K253523 | Freedom DS Decompression System | Spinal Simplicity | Apr 16, 2026 | SESE |
| K252546 | VantageTM Lumbar Decompression Kit | Allevion Medical, LLC | Mar 12, 2026 | SESE |
| K253217 | MiiS Horus Arthroscope (EJA 100); MiiS Horus Endoscope Display System -Tablet (EDS 500); MiiS Horus Endoscope Display System -Video Box (EVS 700) | Medimaging Integrated Solution, Inc (Miis) | Dec 23, 2025 | SESE |
| K250795 | PUREVUE FMS | W.O.M. World of Medicine GmbH | Dec 5, 2025 | SESE |
| K252666 | Articulator Arthroscopic Bur | Joint Preservation Innovations, LLC | Nov 21, 2025 | SESE |
| K252458 | Kyphoplasty Balloon Dilatation Catheters | Shanghai Lange Medtech Co., Ltd. | Nov 3, 2025 | SESE |
| K252020 | TunnelVision Endoscopic Soft Tissue Release System and the HBL Blade Assembly | Hand Biomechanics Lab, Inc. | Oct 15, 2025 | SESE |
| K252594 | UltraGuideCTR® image guided soft tissue release system | Sonex Health | Sep 29, 2025 | SESE |
| K243774 | ELID (Endoscopic Less Invasive Decompression) System | Lesspine Innovations | Aug 27, 2025 | SESE |
| K241990 | SpineSite Endoscope System | Hydrocision, Inc. | Jul 30, 2025 | SESE |
| K243602 | Arthrex Spine Endoscope | Arthrex, Inc. | May 16, 2025 | SESE |
| K242417 | VECTR Video Endoscopic Carpal Tunnel Release System | Rafael Medical Devices, LLC | Dec 11, 2024 | SESE |
| K243020 | MIDASVu | Intravu, Inc. | Dec 2, 2024 | SESE |
| K233800 | Vertos mild Device Kit (MDK-0002) | Vertos Medical, Inc. | May 6, 2024 | SESE |
| K240535 | Digital ClarusScope System; Digital NeuroPEN System | Clarus Medical, LLC | Apr 25, 2024 | SESE |
| K233675 | FMS VUE Fluid Management and Tissue Debridement System | DePuy Mitek, Inc. | Feb 26, 2024 | SESE |
| K233115 | Hawkeye Control Unit with Eyas Endoscope | E Surgical, LLC | Feb 6, 2024 | SESE |
| K223709 | Kyphoplasty Balloon Catheter | Jiangsu Changmei Medtech Co., Ltd. | Aug 16, 2023 | SESE |
| K221142 | Kyphoplasty Balloon System | OK Medinet Korea Co., Ltd. | Apr 21, 2023 | SESE |
| K221919 | DOUBLEFLO INFLOW/OUTFLOW PUMP, accessories and tubing sets | Hemodia Sas | Mar 9, 2023 | SESE |
| K223406 | SmartRelease Endoscopic Soft Tissue Release System | Microaire Surgical Instruments | Feb 2, 2023 | SESE |
| K223244 | Pristine Arthroscopic Visualization System | Pristine Surgical | Dec 21, 2022 | SESE |
| K222490 | HBL Blade Assembly | Hand Biomechanics Lab, Inc. | Nov 14, 2022 | SESE |
| K213978 | TELIGEN System | Medos International SARL | Oct 18, 2022 | SESE |
| K212636 | CORUS Spinal System-X | Providence Medical Technology, Inc. | Oct 15, 2021 | SESE |
| K212556 | mi-eye 3 needlescope with cannula, mi-tablet 3 | Trice Medical, Inc. | Sep 15, 2021 | SESE |
| K211297 | SMARTRELEASE Endoscopic Soft Tissue Release System | Microaire Surgical Instruments | Jun 24, 2021 | SESE |
| K203480 | DOUBLEFLO system | Hemodia Sas | Apr 5, 2021 | SESE |
| K202027 | Balex bone Expander System | Taeyeon Medical Co., Ltd. | Feb 3, 2021 | SESE |
| K193608 | EBERLE Shaver System C3 and Accessories | Eberle GmbH & Co. KG | Jan 15, 2021 | SESE |
| K203526 | C Scope Visualization System | Cit Ortho | Jan 12, 2021 | SESE |
| K201113 | Resascope RS-01/B | Advanced Medical Systems Group Srl | Dec 21, 2020 | SESE |
| K202659 | Stryker Arthroscope | Stryker | Dec 1, 2020 | SESE |
| K192921 | Zeos Aqua Vision Pump and tube | Hemodia Sas | Oct 9, 2020 | SESE |
| K200067 | MectaScope System | Medacta International S.A. | Oct 1, 2020 | SESE |
| K200763 | Osteo-site Vertebral Balloon | Izi Medical | Aug 12, 2020 | SESE |
| K201349 | Smith+Nephew Arthroscopes | Smith & Nephew | Jul 20, 2020 | SESE |
| K200729 | HydroCision SpineJet System | Hydrocision, Inc. | Apr 16, 2020 | SESE |
| K191596 | Arcadia Balloon Catheter | Merit Medical Systems, Inc. | Oct 9, 2019 | SESE |
| K192155 | Smith & Nephew DYONICS 25 Fluid Management System | Smith & Nephew, Inc. | Sep 4, 2019 | SESE |
| K191345 | Pegasus System | A.M. Surgical, Inc. | Jul 17, 2019 | SESE |
| K191259 | Stryker CrossFlow Integrated Arthroscopy Pump | Stryker Corp. | Jul 12, 2019 | SESE |
| K191594 | Nuvis Battery Arthroscope | Integrated Endoscopy, Inc. | Jul 11, 2019 | SESE |
| K191579 | Voyant System | Viseon, Inc. | Jul 11, 2019 | SESE |
| K190804 | HydroCision TenJet Device | Hydrocision, Inc. | Jun 5, 2019 | SESE |
| K182287 | MEDINAUT Plus | Imedicom Co., Ltd. | Apr 6, 2019 | SESE |
| K190598 | CROSSWAY Spinal Access System | Globus Medical, Inc. | Apr 5, 2019 | SESE |
| K190201 | CORUS Spinal System | Providence Medical Technology, Inc. | Mar 8, 2019 | SESE |
| K183165 | Pristine Scope | Pristine Surgical | Jan 16, 2019 | SESE |
| K183470 | Precision Ideal Eyes Arthroscopes | Stryker | Jan 7, 2019 | SESE |
| K181752 | Stryker iVAS Elite Inflatable Vertebral Augmentation System (Stryker iVAS Elite Balloon Catheter) | Stryker Corporation | Dec 21, 2018 | SESE |
| K182882 | CrystalView Pro Irrigation Console, CrystalView Pro Autoclavable Remote Control | Conmed Corporation | Nov 14, 2018 | SESE |
| K181819 | SMARTRELEASE Endoscopic Soft Tissue Release System | Microaire Surgical Instruments, LLC | Nov 6, 2018 | SESE |
| K181885 | Voyant System | Viseon, Inc. | Oct 2, 2018 | SESE |
| K181982 | MIDAScope and Introducer Kit, and MIDASystem | Intravu, Inc. | Aug 21, 2018 | SESE |
| K180766 | Endiscope, Endiscope Cervical | Elliquence, LLC | Jun 11, 2018 | SESE |
| K170703 | Single Use Arthroscopic Electrode (with Pencil) | Modern Medical Equipment Manufacturing Limited | May 31, 2018 | SESE |
| K180876 | DTRAX Spinal System | Providence Medical Technology, Inc. | May 18, 2018 | SESE |
| K173311 | ARTHRO-Pump PA304 | W.O.M. World of Medicine GmbH | May 9, 2018 | SESE |
| K180315 | DISKOM | Biopsybell S.R.L. | Mar 26, 2018 | SESE |
| K172116 | Stryker iVAS Elite Inflatable Vertebral Augmentation System (Stryker iVAS Elite Balloon Catheter) | Stryker Corporation | Jan 25, 2018 | SESE |
| K171237 | FMS VUE II Fluid Management and Tissue Debridement System | Medos International SARL | Jan 18, 2018 | SESE |
| K172092 | Reprocessed Shavers/Burs | Renovo, Inc. | Oct 4, 2017 | SESE |
| K171794 | Smith & Nephew 25 Fluid Management System | Smith & Nephew, Inc. | Jun 27, 2017 | SESE |
| K162070 | JOINIX CANNULAR SYSTEM | Aju Pharm Co., Ltd. | Mar 16, 2017 | SESE |
| K163037 | Intra medullary endo-transilluminating device (iMET device) | WeMED Bio-Tech, Inc. | Feb 17, 2017 | SESE |
| K162062 | AVAmax Vertebral Balloon, AVAflex Vertebral Balloon | Stryker Corporation | Nov 1, 2016 | SESE |
| K161878 | PORTAGE System | Baylis Medical Company, Inc. | Sep 26, 2016 | SESE |
| K162475 | mi-eye 2, mi-eye 2 monitor | Trice Medical | Sep 16, 2016 | SESE |
| K152511 | Neo - Arthroscope (Rigid) 2.0mm/3.5mm, Outer sheath/ cannula, Outer sheath/ cannula w/ Handle, Trocar for outersheath/ cannula | Prosurg, Inc. | Jul 11, 2016 | SESE |
| K160249 | ULTRA Telescopes | Olympus Winter & Ibe GmbH | Apr 21, 2016 | SESE |
| K151932 | Stryker CrossFlow Day-Use Inflow Cassette Tubing and Patient-Use Tubing | Stryker Corporation | Mar 31, 2016 | SESE |
| K151268 | SPINAUT-V, SPINAUT-S, SPINAUT-I | Imedicom Co., Ltd. | Mar 16, 2016 | SESE |
| K153548 | VS3 STEREOSCOPIC HIGH DEFINITION VISION SYSTEM | Visionsense, Ltd. | Feb 22, 2016 | SESE |
| K151125 | AVAflex Vertebral Balloon System | Care Fusion | Nov 24, 2015 | SESE |
| K150523 | AVAmax Vertebral Balloon | Care Fusion | Oct 29, 2015 | SESE |
| K151532 | KYPHON ELEMENT Inflatable Bone Tamp | Medtronic, Inc. | Jul 23, 2015 | SESE |
| K143705 | NeedleCam HD Visualization System | Biovision Technologies, LLC | Feb 20, 2015 | SESE |
| K141557 | HERNIATOME PERCUTANEOUS DISECTOMY DEVICE - CERVICAL, HERNIATOME PERCUTANEOUS DISECTOMY DEVICE - LUMBAR | Gallini Medical Devices, Srl | Dec 8, 2014 | SESE |
| K141326 | NEEDLE VIEW CH SCOPE KITS | Biovision Technologies, LLC | Oct 8, 2014 | SESE |
| K141119 | CAMERA ENABLED PROBE | Trice Medical, Inc. | Jul 29, 2014 | SESE |
| K140903 | NUVIS ARTHROSCOPE | Integrated Endoscopy, Inc. | Jul 17, 2014 | SESE |
| K141002 | VS3 STEREOSCOPIC HIGH DEFINITION VISION SYSTEM | Visionsense, Ltd. | Jun 26, 2014 | SESE |
| K133682 | SCHOELLY ARTHROSCOPE | Scholly Fiberoptic GmbH | Jun 2, 2014 | SESE |
| K133941 | MITEK ARTHROSCOPES | Medos International SARL | Apr 18, 2014 | SESE |
| K130778 | DISCOSCOPES, CERVICAL ENDOSCOPES | Rz Medizintechnik GmbH | Apr 14, 2014 | SESE |
| K133018 | OSI Q SYSTEM ARTHROSCOPES | Orthopedic Sciences, Inc. | Feb 26, 2014 | SESE |
| K133061 | ESPIN SYSTEM | Nlt Spine, Ltd. | Nov 27, 2013 | SESE |
| K132883 | HEMODIA ARTHROSCOPY PUMP TUBE SETS (HATS) | Hemodia Sas | Nov 1, 2013 | SESE |
| K131820 | AVAMAX VERTEBRAL BALLOON SYSTEM, 8G, AVAMAX VERTEBRAL BALLOON SYSTEM, 10G, AVAMAX VERTEBRAL BALLOON SYSTEM, 11G | Care Fusion | Oct 4, 2013 | SESE |
| K131824 | AVAFLEX VERTEBRAL BALLOON SYSTEM | Care Fusion | Oct 3, 2013 | SESE |
| K131191 | 4MM & 5MM FULL RADIUS BLADE PLUS, 4MM & 5MM BARREL BUR PLUS/4MM BARREL TORNADO BUR PLUS, 4MM & 5MM AGGRESSIVE BLADE PLUS | Depuy Mitek, A Johnson & Johnson Company | Jul 22, 2013 | SESE |
| K130912 | OMNICUT RESECTION BLADE | Depuy Mitek, A Johnson & Johnson Company | Jun 14, 2013 | SESE |
| K130430 | IVAS 10MM AND 15MM BALLOON CATHETER | Stryker Corporation | May 23, 2013 | SESE |
| K130169 | FMS VUE FLUID MANAGMENT SYSTEM, FMS CONNECT INTERFACE CABLE | Depuy Mitek, A Johnson & Johnson Company | May 1, 2013 | SESE |
| K122411 | J-SCOPE SYSTEM | Myelotec | Feb 11, 2013 | SESE |
| K130057 | ESPIN | Nlt Spine, Ltd. | Feb 7, 2013 | SESE |
| K123441 | STRYKER CROSSFLOW ARTHROSCOPY PUMP | Stryker Endoscopy | Jan 9, 2013 | SESE |
| K121261 | ASAP MUITISCOPE | Asap Endoscopic Products GmbH | Jan 8, 2013 | SESE |
| K122134 | FLEXLITE CAMERA | Spine View, Inc. | Dec 27, 2012 | SESE |
| K123771 | KYPHON EXPRESS II INFLATABLE BONE TAMPS | Medtronic | Dec 21, 2012 | SESE |
| K122861 | XTOOL | Ouroboros Medical | Dec 7, 2012 | SESE |
| K122662 | VERTIFLEX DIRECT DECOMPRESSION SYSTEM | Vertiflex, Inc. | Nov 13, 2012 | SESE |
| K121482 | INSTRUMENT SYSTEM FOR ENDOSCOPIC SPINAL SURGERY | Theken Spine, LLC | Aug 28, 2012 | SESE |
| K121548 | SPINEVU ENDOSCOPIC SPINE SYSTEM (SESS) | Spine View, Inc. | Aug 16, 2012 | SESE |
| K112548 | ALTOMEC ARTHROSCOPE | Altomec Endoscopy, Inc. | Aug 15, 2012 | SESE |
| K120553 | ESPIN | Nlt Spine, Ltd. | Aug 9, 2012 | SESE |
| K120680 | ENSPIRE DISCECTOMY SYSTEM | Spine View, Inc. | Jun 26, 2012 | SESE |
| K113352 | TRANSCORP SPINAL ACCESS SYSTEM | Transcorp, Inc. | Apr 16, 2012 | SESE |
| K113362 | SPINEVU ENDOSCOPIC SPINE SYSTEM (SESS) | Spine View, Inc. | Feb 10, 2012 | SESE |
| K113028 | MEDISISS REPROCESSED ARTHROSCOPIC SHAVERS AND BURS | Medisiss | Dec 20, 2011 | SESE |
| K110992 | ENSPIRE DEBRIDER SYSTEM | Spine View, Inc. | Oct 21, 2011 | SESE |
| K103231 | KYPHON INFLATION SYRINGE | Medtronic Spine, LLC | Jan 24, 2011 | SESE |
| K093471 | KARL STORZ ARTHROPUMP POWER IRRIGATION/SUCTION PUMP | KARL STORZ Endoscopy-America, Inc. | Oct 18, 2010 | SESE |
| K101864 | KYPHON XPANDER II INFLATABLE BONE TAMP | Medtronic | Oct 14, 2010 | SESE |
| K092723 | AKRO VU VIDEOSCOPIC CARPAL TUNNEL RELEASE (VCTR) SYSTEM | Skeletal Dynamics, LLC | Oct 4, 2010 | SESE |
| K092977 | EBERLE SHAVER SYSTEM ACCESSORIES | Efs Eberle Feinwerktechnische Systeme | Sep 29, 2010 | SESE |
| K101734 | VISIONSCOPE HIGH DEFINITION ENDOSCOPY CAMERA SYSTEM WITH; CAMERA CONTROL UNIT; CAMERA HANDPIECE; VISIONSCOPE ENDOSCOPES | Visionscope Technologies, LLC | Sep 8, 2010 | SESE |
| K093677 | STRYKER ARTHROSCOPE | Stryker Endoscopy | Mar 5, 2010 | SESE |
| K093717 | C-MOR VISUALIZATION DEVICE | Axis Surgical Technologies, Inc. | Mar 2, 2010 | SESE |
| K093409 | POWERPUMP ARTHROSCOPY SYSTEM | Medical Vision AB | Feb 24, 2010 | SESE |
| K093062 | VERTOS MEDICAL MILD DEVICE KIT | X-Sten Corp. | Feb 4, 2010 | SESE |
| K092877 | INDISCAL ASPIRATION DEVICE AND ACCESSORIES | Baylis Medical Co., Inc. | Nov 17, 2009 | SESE |
| K083552 | MAXMORESPINE TOM STICK | Hoogland Spine Products, GmbH | Oct 9, 2009 | SESE |
| K082841 | SPINAL FORAMINOSCOPE | Blazejewski Medi-Tech GmbH | Sep 9, 2009 | SESE |
| K091398 | ARTHROSCOPE | Orthopedic Sciences, Inc. | Aug 26, 2009 | SESE |
| K083707 | ARTHREX DUAL WAVE ARTHROSCOPY FLUID MANAGEMENT DEVICE | Arthrex, Inc. | Aug 3, 2009 | SESE |
| K090132 | MAXMORESPINE SPINAL SYSTEM | Hoogland Spine Products, GmbH | Jun 9, 2009 | SESE |
| K090815 | PERCUTANEOUS DISCECTOMY SYSTEM | Laurimed, LLC | May 21, 2009 | SESE |
| K090303 | XTEND-ST NUCLEUS REMOVAL SYSTEM, MODEL 9004 | Corespine Technologies, LLC | Apr 30, 2009 | SESE |
| K090278 | ENSPIRE DEBRIDER SYSTEM | Spine View, Inc. | Apr 15, 2009 | SESE |
| K083161 | ZEN WIRELESS FOOTSWITCH (W1000), ZEN WIRELESS FOOTSWITCH ADAPTER (W1100) | Conmed Linvatec | Mar 27, 2009 | SESE |
| K081240 | TIGER DISCECTOMY DEVICE | Spinal Devices, LLC | Feb 27, 2009 | SESE |
| K082355 | VISIONSENSE STEREOSCOPIC VISION SYSTEM | Visionsense, Ltd. | Dec 15, 2008 | SESE |
| K082293 | SURGVIEW INTEGRATED VISUALIZATION SYSTEM | Biovision Technologies, LLC | Sep 9, 2008 | SESE |
| K082194 | LAURIMED PERCUTANEOUS DISCECTOMY SYSTEM, MODEL FG-000002 | Laurimed, LLC | Aug 28, 2008 | SESE |
| K081051 | SPINEVU ENDOSCOPIC SPINE SYSTEM (SESS), SPINEVU MINISCOPE | Spine View, Inc. | Aug 7, 2008 | SESE |
| K080122 | SOPRO 670 ARTHROSCOPIC PUMP | Sopro | Jul 11, 2008 | SESE |
| K080617 | POWER DRIVE ART1 2304 WITH MOTOR HANDLES, TOOLS AND ACCESSORIES | Richard Wolf Medical Instruments Corp. | Jun 27, 2008 | SESE |
| K072198 | X-VOID, SPIDER | Sintea Biotech, Inc. | Jun 6, 2008 | SESE |
| K080560 | HENKE SASS WOLF OF AMERICA ARTHROSCOPE | Henke Sass Wolf of America, Inc. | Mar 18, 2008 | SESE |
| K072879 | INNERVUE DIAGNOSTIC SCOPE SYSTEM | Biomet Orthopedics, Inc. | Jan 14, 2008 | SESE |
| K070021 | ITALITE , MODEL 500-3.1, 550-3.1, 600-3.1, 650-3.1, 450-2.0,400-2.0 | Jg Medical Products, LLC | Dec 7, 2007 | SESE |
| K070874 | ARTHRO KINETICS VESALIUS MR GENERATOR, MODELS 2004-2006; ACCESSORIES FOR MR GENERATOR | Arthro Kinetics, Inc. | Nov 2, 2007 | SESE |
| K072706 | MICROCHOICE DRILLS AND SAWS, MICROPOWER DRILLS AND SAWS, MICROPOWER ORALMAX HIGH SPEED DRILL | Conmed Linvatec | Oct 24, 2007 | SESE |
| K072675 | SMITH & NEPHEW ARTHROSCOPE | Smith & Nephew, Inc. | Oct 15, 2007 | SESE |
| K070233 | CONMED LINVATEC SMART GUARD IRRIGATOR | Conmed Linvatec | Apr 2, 2007 | SESE |
| K063326 | CONMED LINVATEC 24K IRRIGATION SYSTEM | Conmed Linvatec | Jan 31, 2007 | SESE |
| K062849 | SMITH & NEPHEW DUONICS POWER II SHAVER SYSTEM | Smith & Nephew, Inc. | Jan 19, 2007 | SESE |
| K062038 | X-STEN MILD TOOL KIT, MODEL MTK-0001 | X-Sten Corp. | Dec 19, 2006 | SESE |
| K062380 | FLOSIMPLE ARTHROSCOPY PUMP A120 | W.O.M. World of Medicine AG | Dec 14, 2006 | SESE |
| K061134 | EBERLE SHAVER SYSTEM C2 AND SHAVER BLADES | Efs Eberle Feinwerktechnische Systeme | Sep 1, 2006 | SESE |
| K061246 | ENDOSCOPIC SPINE SYSTEM | Arthro Kinetics, Inc. | Aug 23, 2006 | SESE |
| K061345 | MODIFICATION TO ENDIUS ATAVI SYSTEM | Endius, Inc. | Jun 6, 2006 | SESE |
| K060172 | REMA SHAVER BLADES | Rema Medizintechnik GmbH. | May 31, 2006 | SESE |
| K060198 | MICROPOWER HAND PIECE : MEDIUM SPEED DRILL, SAGGITAL SAW, RECIPROCATING SAW, AND OSCILLATING SAW | Linvatec Corp. | May 11, 2006 | SESE |
| K053567 | ATHROCARE TOPAZ ARTHROWANDS | Arthrocare Corp. | Mar 6, 2006 | SESE |
| K052241 | DISC-FX SYSTEM | Ellman International, Inc. | Feb 24, 2006 | SESE |
| K053267 | ENDIUS ATAVI SYSTEM | Endius, Inc. | Jan 13, 2006 | SESE |
| K051656 | OCT (OSTEOCHONDRAL TRANSPLANT) COMPREHENSIVE SYSTEM | Osteobiologics, Inc. | Oct 25, 2005 | SESE |
| K051827 | JOIMAX ENDOSCOPE/MULTISCOPE, THESSYS FORAMINOSCOPE/MULTISCOPE, THESSYS LAMINOSCOPE/MULTISCOPE | Joimax GmbH | Aug 12, 2005 | SESE |
| K051326 | SMITH & NEPHEW 25 FLUID MANAGEMENT SYSTEM | Smith & Nephew, Inc. | Jun 15, 2005 | SESE |
| K050580 | SMITH & NEPHEW INTELIJET FLUID MANAGEMENT SYSTEMS | Smith & Nephew Endoscopy, Inc. | Apr 20, 2005 | SESE |
| K043568 | EQUESTRA FLUID DELIVERY SYSTEM | Medtronic Sofamor Danek | Jan 25, 2005 | SESE |
| K043395 | SMITH & NEPHEW VIDEOARTHROSCOPE | Smith & Nephew, Inc. | Jan 12, 2005 | SESE |
| K041824 | X-TREME ARTHROSCOPIC PUMP AND SHAVER SYSTEM | Future Medical Systems, SA | Jan 7, 2005 | SESE |
| K041233 | ARTHROJET XT | Hydrocision, Inc. | Jul 28, 2004 | SESE |
| K040483 | EQUESTRA FLUID DELIVERY SYSTEM | Medtronic Sofamor Danek, Inc. | Jul 23, 2004 | SESE |
| K041454 | KYPHX XPANDER INFLATABLE BONE TAMPS MODEL#KO8A,KO9A,K13A | Kyphon, Inc. | Jul 9, 2004 | SESE |
| K040612 | SKY BONE EXPANDER SYSTEM (SKY SYSTEM) | Disc-O-Tech Medical Technologies, Ltd. | Jun 17, 2004 | SESE |
| K040919 | NUCLEOTOME PROBE SET, MODEL 21200 | Clarus Medical, LLC | Jun 1, 2004 | SESE |
| K040939 | SKY BONE EXPANDER SYSTEM (SKY SYSTEM) | Disc-O-Tech Medical Technologies, Ltd. | May 12, 2004 | SESE |
| K041135 | VAPR 3 ELECTROSURGICAL SYSTEM AND VAPR LD AND LP SUCTION ELECTRODES | Depuy Mitek, A Johnson & Johnson Company | May 10, 2004 | SESE |
| K033573 | LINVATEC 10K IRRIGATION SYSTEM | Linvatec Corp. | Feb 11, 2004 | SESE |
| K034037 | SKY BONE EXPANDER SYSTEM | Disc-O-Tech Medical Technologies, Ltd. | Jan 28, 2004 | SESE |
| K033927 | ARTHOSCOPY PUMP A115 | W.O.M. World of Medicine AG | Jan 15, 2004 | SESE |
| K032891 | TRANS1 TRANS-SACRAL SPINAL ACCESS AND PREPARATION KIT | Trans1, Inc. | Jan 15, 2004 | SESE |
| K032358 | B-TWIN BONE EXPANDER SYSTEM (B-TWIN BE SYSTEM) | Disc-O-Tech Medical Technologies, Ltd. | Dec 17, 2003 | SESE |
| K032473 | DEKOMPRESSOR PERCUTANEOUS DISCECTOMY PROBE | Stryker Instruments | Nov 7, 2003 | SESE |
| K030082 | POWER CONTROL 2303 WITH POWER STICK M4, MODEL# 2303.011/.901/.911, 8564.121/.851 | Richard Wolf Medical Instruments Corp. | Oct 30, 2003 | SESE |
| K032832 | IRRIGATION SETS | Vital Concepts, Inc. | Sep 26, 2003 | SESE |
| K032529 | HYDROCISION ARTHROJET SYSTEM WITH CAUTERY, TURBOBURR AND CURETTE, MODELS 51300, 51310 | Hydrocision, Inc. | Sep 16, 2003 | SESE |
| K032212 | KYPHX DIRECTIONAL INFLATABLE BONE TAMP, MODELS K16A AND K17A | Kyphon, Inc. | Sep 15, 2003 | SESE |
| K031972 | ASAP ARTHROSCOPE MODELS; 10-0001-00, 10-0002-00, 10-0003-00, 10-0004-00, 10-0005-00, 10-0006-00, 10-0007-00, 10-0008-00, | Asap Endoscopic Products GmbH | Sep 15, 2003 | SESE |
| K031605 | INTELIJET FLUID MANAGEMENT SYSTEM HERMES-READY | Smith & Nephew, Inc. | Jun 18, 2003 | SESE |
| K031406 | EXOJET TISSUE MANAGEMENT SYSTEM | Mitek Worldwide | May 30, 2003 | SESE |
| K030402 | ARTHROSCOPY PUMP, MODEL A107 | W.O.M. World of Medicine AG | Apr 17, 2003 | SESE |
| K030009 | KSEA POWERSHAVER SYSTEM S2 | Karl Storz Endoscopy | Apr 2, 2003 | SESE |
| K024291 | ARTHREX CONTINUOUS WAVE III ARTHOSCOPY PUMP, MODEL AR-6475 | Arthrex, Inc. | Mar 20, 2003 | SESE |
| K030096 | VIDEO ARTHROSCOPE, MODELS AR-3050-30, AR-3050T-30, AR-3050-70, AR-3051-30, AR-3052-30, AR3030AN, AR-3030AS, AR3030AW | Arthrex, Inc. | Mar 18, 2003 | SESE |
| K030196 | DYONICS POWER CONTROL UNIT | Smith & Nephew, Inc. | Feb 20, 2003 | SESE |
| K030307 | DAVOL ARTHROVENT OUTFLOW TUBING | Davol, Inc. | Feb 13, 2003 | SESE |
| K023783 | SOHNIKS | Sohniks Endoscopy, Inc. | Feb 7, 2003 | SESE |
| K023777 | ARTHRONET BLACKLINE 2 AND 3 PIECE ARTHROSCOPIC BLADES, MODELS 123, 133, 153, 163, 173 AND 183 | Arthronet Medical, Inc. | Dec 11, 2002 | SESE |
| K023187 | KSEA SPINOSCOPE | Karl Storz Endoscopy | Dec 2, 2002 | SESE |
| K022199 | ENDIUS ATAVI SYSTEM | Endius, Inc. | Oct 2, 2002 | SESE |
| K020457 | AXIAMED TRANS-SACRAL SPINAL ACCESS DEVICE | Axiamed, Inc. | Sep 26, 2002 | SESE |
| K022578 | ENDIUS FLEXTIP BLADE | Endius, Inc. | Aug 23, 2002 | SESE |
| K021748 | ENDIUS ATAVI SYSTEM | Endius, Inc. | Jun 26, 2002 | SESE |
| K012667 | REPROCESSED ARTHROSCOPIC SHAPERS | Surgical Instruments Service and Savings, Inc. | Jun 3, 2002 | SESE |
Top Applicants
- KARL STORZ Endoscopy-America, Inc. — 28 clearances
- Arthrex, Inc. — 27 clearances
- Acufex Microsurgical, Inc. — 26 clearances
- Linvatec Corp. — 19 clearances
- Smith & Nephew, Inc. — 18 clearances
