FDA Product Code
FDA Product Code HRX — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Orthopedic
- 21 CFR Citation
- 888.1100
510(k) Clearances — 683 records · page 4 of 7
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K964879 | PNEUMATIC ARTHROSCOPY PULSED IRRIGATOR SYSTEM MODEL 0027030 AND BATTERY ARTHROSCOPY PULSED IRRIGATOR SYSTEM | Davol Inc., Sub. C. R. Bard, Inc. | 1997-03-04 | Traditional | PDF ↗ |
| K964975 | COHORT DISCECTOMY SYSTEMS (CDS) | Cohort Medical Products Group, Inc. | 1997-02-24 | Traditional | PDF ↗ |
| K964919 | EMERALD MEDICAL, INC. NUCLEUS PULPOSIS EVACUATOR SYSTEM | Emerald Medical, Inc. | 1997-01-28 | Traditional | PDF ↗ |
| K963304 | STRYKER TEMPEST ORTHOPEDIC PUMP | Stryker Endoscopy | 1997-01-22 | Traditional | PDF ↗ |
| K962075 | HSW GMBH ARTHROSCOPE | Henke Sass Wolf of America, Inc. | 1997-01-17 | Traditional | PDF ↗ |
| K964215 | ACUFEX MOSAICPLASTY COMPREHENSIVE SYSTEM | Smith & Nephew Endoscopy, Inc. | 1996-12-20 | Traditional | PDF ↗ |
| K963029 | KARL STORZ SLOTTED WHISKER ARTHROSCOPIC BLADE | KARL STORZ Endoscopy-America, Inc. | 1996-11-27 | Traditional | PDF ↗ |
| K963524 | KSEA LARGE JOINT ARTHROSCOPY SET | Karl Storz Endoscopy | 1996-11-14 | Traditional | PDF ↗ |
| K963332 | THERMO-PLASTIC SHAVER BLADES | Stryker Endoscopy | 1996-10-11 | Traditional | PDF ↗ |
| K961228 | KARL STORZ MAGNIFYING ARTHROSOCPES | KARL STORZ Endoscopy-America, Inc. | 1996-10-10 | Traditional | PDF ↗ |
| K961590 | APEX UNIVERSAL IRRIGATION SYSTEM & TWO-CONNECTION TUBING SET | Linvatec Corp. | 1996-10-08 | Traditional | PDF ↗ |
| K962330 | AMO ARTHOSCOPES | American Microptiks, Inc. | 1996-09-11 | Traditional | PDF ↗ |
| K960194 | MYELOTEC MYELOSCOPE | Myelotec, Inc. | 1996-09-04 | Traditional | PDF ↗ |
| K962114 | ARTHRO-SURGIMAT | W.O.M. World of Medicine GmbH | 1996-08-22 | Traditional | PDF ↗ |
| K962321 | ARTHOCARE ARTHROSCOPIC ELECTROSURGERY SYSTEM MODEL 970 | Arthrocare Corp. | 1996-07-19 | Traditional | PDF ↗ |
| K961747 | ARTHROCARE ARTHROSCOPIC ELECTROSURGERY SYSTEM (MODEL 970) | Arthrocare Corp. | 1996-07-15 | Traditional | PDF ↗ |
| K961853 | PROLINE FAST PASS ARTHOSCOPIC NEEDLE PASSER | Acufex Microsurgical, Inc. | 1996-06-21 | Traditional | PDF ↗ |
| K961713 | INSTRUMENT SET FOR ARTHROSCOPIC PERCUTANEOUS DISCECTOMY | KARL STORZ Endoscopy-America, Inc. | 1996-05-31 | Traditional | PDF ↗ |
| K961244 | KSEA INSTRUMENTS FOR ENDOSCOPIC TREATMENT OF CARPAL TUNNEL SYNDROME | KARL STORZ Endoscopy-America, Inc. | 1996-05-07 | Traditional | PDF ↗ |
| K960805 | ARTHOSCOPE | United States Surgical, A Division of Tyco Healthc | 1996-04-10 | Traditional | PDF ↗ |
| K960046 | SURGICAL DYNAMICS 30K WORKING CHANNEL SCOPE | Surgical Dynamics, Inc. | 1996-04-02 | Traditional | PDF ↗ |
| K960222 | PERCUTANEOUS ENDOSCOPIC DISCECTOMY | Richard Wolf Medical Instruments Corp. | 1996-03-08 | Traditional | PDF ↗ |
| K954652 | AESCULAP ENDOSCCOPIC SPINE INSTRUMENTS | Aesculap, Inc. | 1996-02-14 | Traditional | PDF ↗ |
| K955480 | BOZOTTA REINSERTION FORCEPS | KARL STORZ Endoscopy-America, Inc. | 1996-02-09 | Traditional | PDF ↗ |
| K955914 | LIMITED REUSE ARTHROSCOPIC BLADES | Smith & Nephew Dyonics, Inc. | 1996-02-08 | Traditional | PDF ↗ |
| K955500 | FMS ARTHOPROBE | Future Medical Systems, Inc. | 1996-02-05 | Traditional | PDF ↗ |
| K954016 | VIDEOSCOPE W/IRRIGATION SHEATH | T. Korossurgical Instruments Corp. | 1996-01-25 | Traditional | PDF ↗ |
| K953913 | OPTUS ARTHROSCOPE & MINI-ARTHROSCOPE ACCESSORIES | Optus, Inc. | 1996-01-22 | Traditional | PDF ↗ |
| K955652 | KARL STORZ TARGETING UNIT | KARL STORZ Endoscopy-America, Inc. | 1996-01-17 | Traditional | PDF ↗ |
| K954964 | AQUACENTER 2000 SYSTEM | Aquarius Medical Corp. | 1995-12-28 | Traditional | PDF ↗ |
| K954627 | ECTRA II LIGAMENT RELEASE SYSTEM | Smith & Nephew Dyonics, Inc. | 1995-12-18 | Traditional | PDF ↗ |
| K955471 | INCL ENDOSCOPE | Sofamor Danek USA,Inc. | 1995-12-18 | Traditional | PDF ↗ |
| K955273 | CANNULOC THREADED CANNULA | Linvatec Corp. | 1995-12-08 | Traditional | PDF ↗ |
| K955037 | RIGID NEUROVIEW ENDOSCOPE | Neuro Navigational Corp. | 1995-12-04 | Traditional | PDF ↗ |
| K954981 | KARL STORZ HEMPFLING DILATION SET | KARL STORZ Endoscopy-America, Inc. | 1995-12-04 | Traditional | PDF ↗ |
| K953998 | DISCETOME TISSUE ASPIRATOR | T. Korossurgical Instruments Corp. | 1995-12-04 | Traditional | PDF ↗ |
| K955272 | TAKE-APART ARTHRO-SCISSORS, GASPING, BIOPSY PUNCH FORCEPS FOR ARTHROSCOPY | KARL STORZ Endoscopy-America, Inc. | 1995-12-04 | Traditional | PDF ↗ |
| K946087 | INCLUSICE II(TM) ENDOSCOPE | Sofamor Danek USA,Inc. | 1995-11-21 | Traditional | PDF ↗ |
| K954882 | RIZA-RIBE NEEDLE (MODIFICATION) | R-Med, Inc. | 1995-11-16 | Traditional | PDF ↗ |
| K954510 | RRIANGLE KNIFE | Phx Technologies Corp. | 1995-11-14 | Traditional | PDF ↗ |
| K954507 | RETROGRADE KNIFE | Phx Technologies Corp. | 1995-11-14 | Traditional | PDF ↗ |
| K954508 | RETRACTOR | Phx Technologies Corp. | 1995-11-14 | Traditional | PDF ↗ |
| K954509 | PROBE KNIFE | Phx Technologies Corp. | 1995-11-14 | Traditional | PDF ↗ |
| K954465 | FMS DUO | Future Medical Systems, Inc. | 1995-11-09 | Traditional | PDF ↗ |
| K942029 | ARTHROSCOPE | Surgical Technologies, Inc. | 1995-11-08 | Traditional | PDF ↗ |
| K954014 | PERCUTANEOUS DISCECTOMY CANNULA SYSTEM | T. Korossurgical Instruments Corp. | 1995-11-06 | Traditional | PDF ↗ |
| K954052 | ARTHROSCOPIC GRASPER, CUP FORCEPS AND CURETTES | T. Korossurgical Instruments Corp. | 1995-11-06 | Traditional | PDF ↗ |
| K954440 | APEX TUBING SET | Linvatec Corp. | 1995-11-02 | Traditional | PDF ↗ |
| K954459 | CONICAL OBTURATOR | Phx Technologies Corp. | 1995-10-23 | Traditional | PDF ↗ |
| K954193 | SURGICAL DYNAMICS 30K WORKING CHANNEL SCOPE & INSTRUMENT SET | Surgical Dynamics, Inc. | 1995-10-23 | Traditional | PDF ↗ |
| K954464 | CARPAL TUNNEL SLOTTED CANNULA | Phx Technologies Corp. | 1995-10-23 | Traditional | PDF ↗ |
| K954217 | ARTHROPLAST & ARTHRO-CUTTER | Future Medical Systems, Inc. | 1995-10-23 | Traditional | PDF ↗ |
| K954476 | PROBE | Phx Technologies Corp. | 1995-10-23 | Traditional | PDF ↗ |
| K954475 | BLUNT DISSECTOR, CURVED | Phx Technologies Corp. | 1995-10-23 | Traditional | PDF ↗ |
| K954458 | BOAT NOSE OBTURATOR | Phx Technologies Corp. | 1995-10-23 | Traditional | PDF ↗ |
| K954463 | DISSECTING OBTURATOR | Phx Technologies Corp. | 1995-10-23 | Traditional | PDF ↗ |
| K953659 | ARTHROSCOPIC ELECTROSURGERY SYSTEM (MODIFICATION) | Arthrocare Corp. | 1995-09-29 | Traditional | PDF ↗ |
| K953868 | GRASPING FORCEPS, BIOPSY FORCEPS, SCISSORS, PUNCH | Richard Wolf Medical Instruments Corp. | 1995-09-29 | Traditional | PDF ↗ |
| K930191 | DANEK(TM) SPINAL EPIDURAL ENDOSCOPIC SY | Sofamor Danek Mfg., Inc. | 1995-09-26 | Traditional | PDF ↗ |
| K953695 | DYONICS DISPOSABLE ARTHROSCOPIC BLADES | Smith & Nephew Dyonics, Inc. | 1995-09-15 | Traditional | PDF ↗ |
| K946174 | BLOCK(TM) ARTHROSCOPIC TOOL KIT | Johnson | 1995-09-14 | Traditional | PDF ↗ |
| K944553 | PRESSURE SENSING SCOPE SHEATH SYSTEM | Linvatec Corp. | 1995-09-08 | Traditional | PDF ↗ |
| K952639 | DISPOSABLE TOOTHED GRASPING FORCEP | Neuro Navigational Corp. | 1995-09-08 | Traditional | PDF ↗ |
| K952630 | DISPOSABLE BIOPSY FORCEP | Neuro Navigational Corp. | 1995-09-08 | Traditional | PDF ↗ |
| K944593 | STRYKER PRESSURE SENSING CANNULA | Stryker Endoscopy | 1995-09-01 | Traditional | PDF ↗ |
| K953484 | POLLUX OA/POLLUX 30A/POLLUX 70A | Pollux Endoscopy, Inc. | 1995-09-01 | Traditional | PDF ↗ |
| K953075 | UNIMAT PUMP | KARL STORZ Endoscopy-America, Inc. | 1995-09-01 | Traditional | PDF ↗ |
| K930084 | MICRO-ARTHROSCOPE | Medical Devices, Inc. | 1995-09-01 | Traditional | PDF ↗ |
| K951267 | STRYKER UNIVERSAL ACL INSTRUMENTATION SYSTEM | Stryker Endoscopy | 1995-09-01 | Traditional | PDF ↗ |
| K953550 | CO2 ARTHROFLATOR | KARL STORZ Endoscopy-America, Inc. | 1995-08-23 | Traditional | PDF ↗ |
| K950093 | AMD SYSTEM WORKING CHANNEL SCOPE AND ACCESSORIES | Smith & Nephew Richards, Inc. | 1995-08-15 | Traditional | PDF ↗ |
| K941862 | INTEQ TFCC REPAIR SYSTEM | Linvatec Corp. | 1995-08-14 | Traditional | PDF ↗ |
| K953387 | ECTRA LIGAMENT RELEASE SYSTEM | Smith & Nephew Dyonics, Inc. | 1995-08-09 | Traditional | PDF ↗ |
| K951268 | SPINE-TECH MODIFIED LAPAROSCOPIC SPINAL FUSION INSTRUMENT SYSTEM | Spine-Tech, Inc. | 1995-07-31 | Traditional | PDF ↗ |
| K951624 | ARGUS MEDICAL COMPANY LAPAROSCOPIC DISCECTOMY INSTRUMENT SYSTEM | Argus Medical Co., Inc. | 1995-07-26 | Traditional | PDF ↗ |
| K951843 | REF. 4102CV INTERMEDIARY TUBING, REF. 4509CV STERILE ZONE KIT | Future Medical Systems, Inc. | 1995-07-14 | Traditional | PDF ↗ |
| K951941 | CITATION MULTIPLE USE DELTA SCOPE | Citation Medical Corp. | 1995-07-14 | Traditional | PDF ↗ |
| K950054 | ENDO-BEND(TM) SHAVER | Paladin Medical, Inc. | 1995-06-29 | Traditional | PDF ↗ |
| K945390 | CITATION DELTA SCOPE | Citation Medical Corp. | 1995-06-23 | Traditional | PDF ↗ |
| K946290 | CITATION POWER TOOL | Citation Medical Corp. | 1995-06-15 | Traditional | PDF ↗ |
| K945684 | POC ARTHROSCOPE AND ACCESSORIES | Precision Optics Corp. | 1995-06-14 | Traditional | PDF ↗ |
| K951354 | OLYMPUS ARTHROSCOPY SYSTEM | Olympus America, Inc. | 1995-06-14 | Traditional | PDF ↗ |
| K945787 | KARL STORZ SEMI-RIGID MICRO-ENDOSCOPES AND ACCESSORIES FOR ENDOSCOPIC ARTHROSCOPY PROCEDURES | KARL STORZ Endoscopy-America, Inc. | 1995-06-13 | Traditional | PDF ↗ |
| K944500 | ACUFEX PATELLAR BONE BLOCK SIZER | Acufex Microsurgical, Inc. | 1995-06-12 | Traditional | PDF ↗ |
| K951859 | ACUFEX ENDOBUTTON PACK | Acufex Microsurgical, Inc. | 1995-06-09 | Traditional | PDF ↗ |
| K945891 | KARL STORZ KNIVES, CURETTS, HOOKS, PROBES | KARL STORZ Endoscopy-America, Inc. | 1995-06-09 | Traditional | PDF ↗ |
| K952192 | KARL STORZ UNIDRIVE SHAVER, ARTHROSCOPY BLADES | KARL STORZ Endoscopy-America, Inc. | 1995-06-08 | Traditional | PDF ↗ |
| K951026 | DAVOL ARTHRO-FLO 3 | Davol Inc., Sub. C. R. Bard, Inc. | 1995-06-02 | Traditional | PDF ↗ |
| K951163 | GORE SMOOTHER GUIDED RASP | W. L. Gore & Associates, Inc. | 1995-06-01 | Traditional | PDF ↗ |
| K950592 | ACCESSORIES FOE ORTHOPEDIC SURGICAL PROCEDURES | Eare Consulting Service | 1995-06-01 | Traditional | PDF ↗ |
| K943052 | ARTHROSCOPIC TELESCOPES | Karl Storz Endoscopy | 1995-05-25 | Traditional | PDF ↗ |
| K945267 | OPTUS ARTHROSCOPES AND MINI-ARTHROSCOPES | Optus, Inc. | 1995-05-23 | Traditional | PDF ↗ |
| K940179 | ARTHROSCOPE FOR SMALL JOINT AFTER FELDKAMP, MODEL 8871.011 | Richard Wolf Medical Instruments Corp. | 1995-05-23 | Traditional | PDF ↗ |
| K950242 | ARGUS ARTHROSCOPY INSTRUMENT SYSTEM | Argus Medical Co., Inc. | 1995-05-15 | Traditional | PDF ↗ |
| K950501 | DANEK RIGID ARTHROSCOPE | Sofamor Danek USA,Inc. | 1995-05-12 | Traditional | PDF ↗ |
| K950561 | KSEA DISPOSABLE TUBING SET FOR THE ARTHROPUMP | KARL STORZ Endoscopy-America, Inc. | 1995-05-12 | Traditional | PDF ↗ |
| K943356 | INCLUSIVE ENDOSCOPE | Danek Medical, Inc. | 1995-05-10 | Traditional | PDF ↗ |
| K950705 | 1.2MM DISPOSABLE NEUROVIEW PREFORMED ENDOSCOPE | Neuro Navigational Corp. | 1995-05-09 | Traditional | PDF ↗ |
| K946151 | BENCHMARK SERIES ARTHROSCCOPIC INSTRUMENTS | Depuy, Inc. | 1995-05-09 | Traditional | PDF ↗ |
| K940483 | 2.3 MM DISPOSABLE NEUROVIEW ENDOSCOPE | Neuro Navigational Corp. | 1995-05-02 | Traditional | PDF ↗ |
Product code HRX · Class II · Orthopedic. Data: openFDA.