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 7 of 7
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K881703 | 3M CARPAL TUNNEL | 3M Company | 1988-07-25 | Traditional | PDF ↗ |
| K881792 | CANNULA MODEL AR-6551 | Arthrex Arthroscopy Instruments, Inc. | 1988-07-07 | Traditional | PDF ↗ |
| K880295 | CANNULA MODEL AR-6001 | Arthrex Arthroscopy Instruments, Inc. | 1988-06-29 | Traditional | PDF ↗ |
| K880203 | HERMAN CANNULA SET | Orthopedic Systems, Inc. | 1988-04-14 | Traditional | PDF ↗ |
| K880414 | TENDON HARVESTER | Concept, Inc. | 1988-03-25 | Traditional | PDF ↗ |
| K874911 | MCCAIN INSTRUMENT TMJ/SM. JOINT ARTHROSCOPIC SURG | Walter Lorenz Surgical, Inc. | 1988-02-24 | Traditional | PDF ↗ |
| K880331 | HOOK PUNCH FORCEPS FOR ARTHROSCOPY | Kibbutz Gilgal Medical C/O Toam U.S.A. Corp. | 1988-02-18 | Traditional | PDF ↗ |
| K873331 | ORTHO. GAS INSUFFLATOR MODEL IN-2 FOR ARTHRO. SURG | Directed Energy, Inc. | 1988-02-17 | Traditional | PDF ↗ |
| K880205 | EDWARDS ORTHOPAEDICS ARTHROSCOPES AND ACCESSORIES | Baxter Healthcare Corp | 1988-02-04 | Traditional | PDF ↗ |
| K873619 | ARTHROSCOPIC RETENTION-MANIPULATION SYSTEM (ARMS) | Arthropedics, Inc. | 1988-01-14 | Traditional | PDF ↗ |
| K874515 | CONCEPT SUTURE NEEDLE | Concept, Inc. | 1987-11-27 | Traditional | PDF ↗ |
| K873650 | C-O-T SET (CANNULA, OBTURATOR AND TROCAR) #TM-1360 | Arthropedics, Inc. | 1987-11-02 | Traditional | PDF ↗ |
| K872533 | THE CART | Arthropedics, Inc. | 1987-11-02 | Traditional | PDF ↗ |
| K872986 | MODEL 28200C/SHOULDER/ANKLE/ELBOW/HIP/TMJ/SM JOINT | KARL STORZ Endoscopy-America, Inc. | 1987-10-28 | Traditional | PDF ↗ |
| K871181 | ARTHROCOMBI 5003 | F.M. Wiest USA, Inc. | 1987-09-29 | Traditional | PDF ↗ |
| K871180 | ARTHRO AUTOMAT 5002 | F.M. Wiest USA, Inc. | 1987-09-29 | Traditional | PDF ↗ |
| K873030 | CONCEPT ARTHROSCOPIC PORTAL ROD | Concept, Inc. | 1987-09-16 | Traditional | PDF ↗ |
| K872544 | IRRIGATION PRESSURE MONITOR | Avec Scientific Design Corp. | 1987-09-04 | Traditional | PDF ↗ |
| K872270 | ORTHOCONCEPT ARTHROSCOPIC PUMP ORTHOPUMP | Orthoconcept, Inc. | 1987-07-21 | Traditional | PDF ↗ |
| K871621 | THE KARL STORZ MODEL 28805 ARTHRO PUMP | KARL STORZ Endoscopy-America, Inc. | 1987-06-05 | Traditional | PDF ↗ |
| K870654 | EFER ARTHROSCOPE | Roseburg SA | 1987-05-14 | Traditional | PDF ↗ |
| K865066 | ARTHROFLATOR | F.M. Wiest USA, Inc. | 1987-04-20 | Traditional | PDF ↗ |
| K870915 | SIMPULSE ARTHROSCOPY IRRIGATION SYSTEM | C.R. Bard, Inc. | 1987-04-01 | Traditional | PDF ↗ |
| K864892 | ELLISON ARTHROSCOPY CHEATER | Buckman Co., Inc. | 1986-12-30 | Traditional | PDF ↗ |
| K862017 | ARTHROSCOPIC SHOULDER LIGAMENT REPAIR KIT | Dyonics, Inc. | 1986-12-15 | Traditional | PDF ↗ |
| K864476 | LEG HOLDER | American Container Technology, Inc. | 1986-12-15 | Traditional | PDF ↗ |
| K864513 | LP ARTHROSCOPIC THIGH HOLDING DEVICE | Twin Falls Orthopedic Associates, P.A. | 1986-11-25 | Traditional | PDF ↗ |
| K864163 | HALL DUNBAR DRILL GUIDE SYSTEM | Hall Surgical, Division of Zimmer, Inc. | 1986-11-20 | Traditional | PDF ↗ |
| K863986 | XENON LIGHT SOURCE FOR ENDOSCOPIC PROCEDURES | American Edwards Laboratories | 1986-10-31 | Traditional | PDF ↗ |
| K862990 | CANCELLOUS SCREW | Orthopedic Systems, Inc. | 1986-10-29 | Traditional | PDF ↗ |
| K862991 | LIGAMENT WASHER | Orthopedic Systems, Inc. | 1986-10-29 | Traditional | PDF ↗ |
| K863590 | UNIVERSAL CANNULA SYSTEM | Aspen Laboratories, Inc. | 1986-10-23 | Traditional | PDF ↗ |
| K863605 | ARTHROSCOPIC IRRIGATION PUMP | American Edwards Laboratories | 1986-10-03 | Traditional | PDF ↗ |
| K863597 | AMERICAN EDWARDS 4.0 MM ARTHROSCOPE | American Edwards Laboratories | 1986-09-25 | Traditional | PDF ↗ |
| K863396 | CONCEPT INTRAVISION ARTHROSCOPE SYSTEM | Concept, Inc. | 1986-09-12 | Traditional | PDF ↗ |
| K862778 | HALL CANNLULA SYSTEM | Hall Surgical, Division of Zimmer, Inc. | 1986-09-08 | Traditional | PDF ↗ |
| K862275 | ARTHROSCOPE | Comeg USA, Inc. | 1986-08-11 | Traditional | PDF ↗ |
| K862658 | CONCEPT ARTHROSCOPIC KNIFE | Concept, Inc. | 1986-07-23 | Traditional | PDF ↗ |
| K862657 | CONCEPT CURETTE | Concept, Inc. | 1986-07-23 | Traditional | PDF ↗ |
| K861859 | CABOT VIDEOSCOPE | Cabot Medical Corp. | 1986-05-30 | Traditional | PDF ↗ |
| K861268 | ARTHROSCOPE W/CANNULATED OBTUR/DRILL BITS & WRENCH | Orthopedic Systems, Inc. | 1986-05-16 | Traditional | PDF ↗ |
| K860607 | MARKOPTIC IMPROVED ARTHROSCOPE | Markoptic | 1986-03-05 | Traditional | PDF ↗ |
| K854889 | FLEX-I-GRASP | Euro-Med Intl. | 1986-02-21 | Traditional | PDF ↗ |
| K852759 | AMERICAN EDWARDS LABORATORIES FLEXISCOPE | American Edwards Laboratories | 1985-08-22 | Traditional | PDF ↗ |
| K852592 | CO2 FOR ARTHROSCOPY | The Anspach Effort, Inc. | 1985-08-09 | Traditional | PDF ↗ |
| K851374 | AMERICAN EDWARDS SMALL DIAMETER RIGID ENDOSCOPE | American Edwards Laboratories | 1985-06-28 | Traditional | PDF ↗ |
| K851229 | CODMAN ARTHROSCOPE | Codman & Shurtleff, Inc. | 1985-05-22 | Traditional | PDF ↗ |
| K841241 | ANTERIOR CRUCIATE LIGAMENT GRASPER | Surgical Products Corp. | 1985-02-06 | Traditional | PDF ↗ |
| K843604 | RICHARD ARTHROSCOPE | Richards Medical Co., Inc. | 1984-10-22 | Traditional | PDF ↗ |
| K843208 | ACUFEX ARTHROSCOPE | Acufex Microsurgical, Inc. | 1984-09-11 | Traditional | PDF ↗ |
| K841624 | PROBE | Plastafil, Inc. | 1984-08-27 | Traditional | PDF ↗ |
| K841607 | AMERICAN EDWARDS LABS FLEXISCOPE | American Edwards Laboratories | 1984-08-18 | Traditional | PDF ↗ |
| K842323 | AMER. EDWARDS LAB FLEXISCOPE OBTURATOR | American Edwards Laboratories | 1984-08-17 | Traditional | PDF ↗ |
| K841087 | FLEXIBLE ORTHOPEDIC ENDOSCOPE ICA-1000 | Machida America, Inc. | 1984-05-16 | Traditional | PDF ↗ |
| K834146 | ANTHROSCOPY SYSTEM | Cabot Medical Corp. | 1984-03-08 | Traditional | PDF ↗ |
| K834076 | ARTHROSCOPIC LEG HOLDER 434-21 | Custom Medical Products, Ltd. | 1983-12-27 | Traditional | PDF ↗ |
| K833727 | CABOT ARTHROSCOPY SYSTEM | Cabot Medical Corp. | 1983-12-12 | Traditional | PDF ↗ |
| K833587 | DISPOSABLE ARTHROSCOPY BLADE | Dyonics, Inc. | 1983-11-14 | Traditional | PDF ↗ |
| K832315 | ARTHROSCOPY FLUID MGMT. SYSTEM | 3M Health Care, Sarns | 1983-10-04 | Traditional | PDF ↗ |
| K832341 | ARTHROSCOPE-VARIOUS MODELS FIBEROPTIC | Kamiya Tsusan Kaisha, Ltd. | 1983-10-04 | Traditional | PDF ↗ |
| K832277 | ACUFLEX LEVY ACL DRILL GUIDE SYS | Acufex Microsurgical, Inc. | 1983-08-16 | Traditional | PDF ↗ |
| K831218 | ARTHROSCOPY INFUSION SYS..VALVE | Acufex Microsurgical, Inc. | 1983-07-18 | Traditional | PDF ↗ |
| K831656 | ARTHROSCOPY KNIVES/PROBES/BENDING TOOL | Richards Manufacturer Co. | 1983-06-30 | Traditional | PDF ↗ |
| K831248 | PATELLAR FAT PAD RETRACTOR | Techmedica, Inc. | 1983-06-24 | Traditional | PDF ↗ |
| K830673 | CRAFON ARTHROSCOPY LINES | Gambro, Inc. | 1983-06-08 | Traditional | PDF ↗ |
| K830120 | IMPROVED ARTHROSCOPE | Markoptic | 1983-03-17 | Traditional | PDF ↗ |
| K830499 | ESA ELECTROSURGICAL ARTHROSCOPY GENERA | Concept, Inc. | 1983-03-17 | Traditional | PDF ↗ |
| K823848 | CRAFTON ARTHROSCOPY PUMP AP-10 | Gambro, Inc. | 1983-03-08 | Traditional | PDF ↗ |
| K823832 | ESA ARTHROSCOPY CANNULA TRAY | Concept, Inc. | 1983-02-23 | Traditional | PDF ↗ |
| K823499 | INTRA-ARTICULAR C02 INSUFFLATOR | Surgical Instrument Repair Service Co. | 1983-01-28 | Traditional | PDF ↗ |
| K821672 | PROFLEX | Utah Medical Products, Inc. | 1982-07-22 | Traditional | PDF ↗ |
| K821847 | I.M. ARTHROSCOPE | Instrument Makar, Inc. | 1982-07-22 | Traditional | PDF ↗ |
| K821694 | ARTHROLUX ARTHROSCOPE | Arthro-Tech, Inc. | 1982-07-22 | Traditional | PDF ↗ |
| K821359 | ARTHROSCOPES & ASSOCIATED INSTRUMENTS | Downs Surgical , Ltd. | 1982-05-27 | Traditional | PDF ↗ |
| K820777 | MINI-MICRO ARTHROSCOPIC SCAPEL | The Anspach Effort, Inc. | 1982-05-12 | Traditional | PDF ↗ |
| K820776 | CANNUOATED TROCHAR | The Anspach Effort, Inc. | 1982-04-15 | Traditional | PDF ↗ |
| K820275 | ARTHROSCOPIC HARPOON | The Anspach Effort, Inc. | 1982-02-12 | Traditional | PDF ↗ |
| K820225 | MENISCUS EXTRACTOR | Ortho Pared Instruments, Inc. | 1982-02-04 | Traditional | PDF ↗ |
| K811861 | ARTHROSCOPIC LEG HOLDER | Stryker Corp. | 1981-07-16 | Traditional | PDF ↗ |
| K811596 | ZIMMER ARTHROSCOPY SYSTEM | Zimmer, Inc. | 1981-06-25 | Traditional | PDF ↗ |
| K811675 | SURGICAL INSTRUMENTS FOR USE W/ZIMMER | Zimmer, Inc. | 1981-06-25 | Traditional | PDF ↗ |
| K771200 | ORTHOSCOPE | Stryker Corp. | 1977-07-21 | Traditional | PDF ↗ |
| K770710 | NEEDLE, SPRAY | Richard Wolf Medical Instruments Corp. | 1977-04-26 | Traditional | PDF ↗ |
Product code HRX · Class II · Orthopedic. Data: openFDA.