FDA Product Code
FDA Product Code GEY — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- General, Plastic Surgery
- 21 CFR Citation
- 878.4820
510(k) Clearances — 41 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K050519 | ADVANCED TURBO DRIVE SYSTEM | Linvatec Corp. | 2005-05-17 | Special | PDF ↗ |
| K020621 | ARTHROCARE CONTROLLER; ARTHROCARE CABLE; FOOT CONTROL; POWER CORD; WANDS | Arthrocare Corp. | 2002-03-28 | Special | PDF ↗ |
| K012738 | SYMPHONY GRAFT DELIVERY SYSTEM (GDS) | Depuyacromed | 2001-11-14 | Traditional | PDF ↗ |
| K972308 | MEDNEXT 1000 DRILL | Mednext, Inc. | 1997-08-20 | Traditional | PDF ↗ |
| K971941 | AQUA SPRAY | Boyd Industries, Inc. | 1997-08-14 | Traditional | PDF ↗ |
| K971782 | BONE AND MARROW COLLECTION SYSTEM KIT | Biomedical Ent., Inc. | 1997-07-29 | Traditional | PDF ↗ |
| K971268 | BONE & MARROW CLLECTION SYSTEM | Biomedical International Corp. | 1997-07-03 | Traditional | PDF ↗ |
| K964252 | ORTHOCHUCK | Buckman Co., Inc. | 1997-05-27 | Traditional | PDF ↗ |
| K970530 | ANSPACH LUBRICATING SYSTEM II | The Anspach Effort, Inc. | 1997-05-05 | Traditional | PDF ↗ |
| K964073 | BME BONE DRILL BITS | Biomedical Ent., Inc. | 1996-11-14 | Traditional | PDF ↗ |
| K962789 | SURGICAL KIT-ACUFEX MOSAICPLASTY SYSTEM | Smith & Nephew Endoscopy, Inc. | 1996-08-14 | Traditional | PDF ↗ |
| K961901 | BONE & MARROW COLLECTION SYSTEM | Biomedical Ent., Inc. | 1996-08-06 | Traditional | PDF ↗ |
| K954470 | SURGIMOTOR | W.O.M. World of Medicine GmbH | 1995-12-08 | Traditional | PDF ↗ |
| K951773 | PODOSPRAY DRILL SYSTEM | Darco Intl., Inc. | 1995-10-26 | Traditional | PDF ↗ |
| K952008 | KARL STORZ DRILL | KARL STORZ Endoscopy-America, Inc. | 1995-07-26 | Traditional | PDF ↗ |
| K951118 | 3M MAXI-DRIVER II ELECTRIC SYSTEM | 3M Company | 1995-07-06 | Traditional | PDF ↗ |
| K940535 | AUTO LUBE SYSTEM | The Anspach Effort, Inc. | 1994-03-21 | Traditional | PDF ↗ |
| K934172 | ACRO-POLY, INC. HANDPIECE/ANGLEHEAD ACCESSORIES FOR SURGICAL INSTUMENTS | Acro-Poly, Inc. | 1993-10-27 | Traditional | PDF ↗ |
| K932700 | CUTO(TM) TISSUE MORCELLATION SYSTEM | Linvatec Corp. | 1993-10-15 | Traditional | PDF ↗ |
| K925360 | ES-100 POWER SYSTEM, ES-100 SERIES | Elekta Instruments, Inc. | 1993-09-07 | Traditional | PDF ↗ |
| K913262 | AESCULAP SURGICAL ACCESSORIES | Aesculap, Inc. | 1991-12-30 | Traditional | PDF ↗ |
| K913369 | MICRO-AIRE MODEL 2060 | Micro Surgical Instruments Corp. | 1991-11-01 | Traditional | PDF ↗ |
| K913266 | MICRO-AIRE MODEL 2050E/ELEC HANDPIECE/TROTTLELESS | Micro Surgical Instruments Corp. | 1991-10-21 | Traditional | PDF ↗ |
| K905383 | 2710-000 OSCILLATING SAW, GENERAL ASSEMBLY | Micro Surgical Instruments Corp. | 1991-06-18 | Traditional | PDF ↗ |
| K904682 | VISTEK ELECTRONIC CONTROLLER | Vistek Corp. | 1990-12-18 | Traditional | PDF ↗ |
| K900033 | MICRO-AIRE POWERED MICRO-SURGERY INSTRUMENTS | Micro-Aire Surgical Instruments, Inc. | 1990-02-13 | Traditional | PDF ↗ |
| K882654 | PHYSIOTRON(TM) MICROSURGICAL MOTOR & COOLING SYS. | Surgical Innovators of America, Inc. | 1988-09-20 | Traditional | PDF ↗ |
| K873475 | MICRO-TORQUE HAND ENGINE & ACCESS. DERMABRA. BURS | Mcghan Medical Corp. | 1987-09-11 | Traditional | PDF ↗ |
| K873476 | MINI-MOTOR HAND ENGINE & ACCESS. DERMABRASION BURS | Mcghan Medical Corp. | 1987-09-11 | Traditional | PDF ↗ |
| K853778 | THE DEXTRA PRECISION POWER UNIT | Storz Instrument Co. | 1985-11-13 | Traditional | PDF ↗ |
| K853762 | ISOMETRIC ACL DRILL GUIDE | Orthopedic Systems, Inc. | 1985-10-07 | Traditional | PDF ↗ |
| K853761 | DRILLING TEMPLATE | Orthopedic Systems, Inc. | 1985-10-07 | Traditional | PDF ↗ |
| K850389 | MULTIPLE OUTLET MANIFOLD | The Anspach Effort, Inc. | 1985-03-18 | Traditional | PDF ↗ |
| K843519 | MINUTEMAN CO2 MICROSURG LASER GEN SURG | American Surgical Laser, Inc. | 1984-12-07 | Traditional | PDF ↗ |
| K843517 | MINUTEMAN CO2 MICROSURG LASER DERMATOL- | American Surgical Laser, Inc. | 1984-12-07 | Traditional | PDF ↗ |
| K843518 | MINUTEMAN C02 MICROSURG LASER PODIATRY | American Surgical Laser, Inc. | 1984-12-07 | Traditional | PDF ↗ |
| K842475 | RICHARDS INTRA-ARTICULAR SHAVER MOTOR | Richards Medical Co., Inc. | 1984-09-17 | Traditional | PDF ↗ |
| K841165 | ELECTRO SURGERY SYSTEM | Micro-Aire Surgical Instruments, Inc. | 1984-06-05 | Traditional | PDF ↗ |
| K830153 | RICHARDS INTRA-ARTICULAR SHAVER BLADES | Richard'S Medical Equip., Inc. | 1983-02-28 | Traditional | PDF ↗ |
| K812437 | 150 DRIVER REAMER | Black & Decker(Tm) | 1981-11-02 | Traditional | PDF ↗ |
| K812438 | SAGITTAL SAW | Black & Decker(Tm) | 1981-11-02 | Traditional | PDF ↗ |
Product code GEY · Class I · General, Plastic Surgery. Data: openFDA.