Product code GEY
- Device name
- Motor, Surgical Instrument, Ac-Powered
- Medical specialty
- General, Plastic Surgery
- Device class
- 1
- Regulation number
- 878.4820
- Review panel
- SU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K050519 | ADVANCED TURBO DRIVE SYSTEM | Linvatec Corp. | 2005-05-17 |
| K020621 | ARTHROCARE CONTROLLER; ARTHROCARE CABLE; FOOT CONTROL; POWER CORD; WANDS | Arthrocare Corp. | 2002-03-28 |
| K012738 | SYMPHONY GRAFT DELIVERY SYSTEM (GDS) | Depuyacromed | 2001-11-14 |
| K972308 | MEDNEXT 1000 DRILL | Mednext, Inc. | 1997-08-20 |
| K971941 | AQUA SPRAY | Boyd Industries, Inc. | 1997-08-14 |
| K971782 | BONE AND MARROW COLLECTION SYSTEM KIT | Biomedical Ent., Inc. | 1997-07-29 |
| K971268 | BONE & MARROW CLLECTION SYSTEM | Biomedical International Corp. | 1997-07-03 |
| K964252 | ORTHOCHUCK | Buckman Co., Inc. | 1997-05-27 |
| K970530 | ANSPACH LUBRICATING SYSTEM II | The Anspach Effort, Inc. | 1997-05-05 |
| K964073 | BME BONE DRILL BITS | Biomedical Ent., Inc. | 1996-11-14 |
| K962789 | SURGICAL KIT-ACUFEX MOSAICPLASTY SYSTEM | Smith & Nephew Endoscopy, Inc. | 1996-08-14 |
| K961901 | BONE & MARROW COLLECTION SYSTEM | Biomedical Ent., Inc. | 1996-08-06 |
| K954470 | SURGIMOTOR | W.O.M. World of Medicine GmbH | 1995-12-08 |
| K951773 | PODOSPRAY DRILL SYSTEM | Darco Intl., Inc. | 1995-10-26 |
| K952008 | KARL STORZ DRILL | KARL STORZ Endoscopy-America, Inc. | 1995-07-26 |
| K951118 | 3M MAXI-DRIVER II ELECTRIC SYSTEM | 3M Company | 1995-07-06 |
| K940535 | AUTO LUBE SYSTEM | The Anspach Effort, Inc. | 1994-03-21 |
| K934172 | ACRO-POLY, INC. HANDPIECE/ANGLEHEAD ACCESSORIES FOR SURGICAL INSTUMENTS | Acro-Poly, Inc. | 1993-10-27 |
| K932700 | CUTO(TM) TISSUE MORCELLATION SYSTEM | Linvatec Corp. | 1993-10-15 |
| K925360 | ES-100 POWER SYSTEM, ES-100 SERIES | Elekta Instruments, Inc. | 1993-09-07 |
| K913262 | AESCULAP SURGICAL ACCESSORIES | Aesculap, Inc. | 1991-12-30 |
| K913369 | MICRO-AIRE MODEL 2060 | Micro Surgical Instruments Corp. | 1991-11-01 |
| K913266 | MICRO-AIRE MODEL 2050E/ELEC HANDPIECE/TROTTLELESS | Micro Surgical Instruments Corp. | 1991-10-21 |
| K905383 | 2710-000 OSCILLATING SAW, GENERAL ASSEMBLY | Micro Surgical Instruments Corp. | 1991-06-18 |
| K904682 | VISTEK ELECTRONIC CONTROLLER | Vistek Corp. | 1990-12-18 |
| K900033 | MICRO-AIRE POWERED MICRO-SURGERY INSTRUMENTS | Micro-Aire Surgical Instruments, Inc. | 1990-02-13 |
| K882654 | PHYSIOTRON(TM) MICROSURGICAL MOTOR & COOLING SYS. | Surgical Innovators of America, Inc. | 1988-09-20 |
| K873475 | MICRO-TORQUE HAND ENGINE & ACCESS. DERMABRA. BURS | Mcghan Medical Corp. | 1987-09-11 |
| K873476 | MINI-MOTOR HAND ENGINE & ACCESS. DERMABRASION BURS | Mcghan Medical Corp. | 1987-09-11 |
| K853778 | THE DEXTRA PRECISION POWER UNIT | Storz Instrument Co. | 1985-11-13 |
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| 05430003362280 | WAW SOFTWARE | Devroye Instruments Belgium | 2026-09-21 |
| 05430003362259 | WAW Duo FUE System | Devroye Instruments Belgium | 2026-09-21 |
| 05430003362242 | WAW CHARGING STATION | Devroye Instruments Belgium | 2026-09-21 |
| 05430003362112 | WAW SLIM HANDPIECE | Devroye Instruments Belgium | 2026-09-21 |
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| 05051471036239 | De Soutter Medical | DE SOUTTER MEDICAL LIMITED | 2022-11-28 |
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| 05051471011519 | De Soutter Medical | DE SOUTTER MEDICAL LIMITED | 2022-11-28 |
| 05051471011441 | De Soutter Medical | DE SOUTTER MEDICAL LIMITED | 2022-11-28 |
| 05051471010697 | De Soutter Medical | DE SOUTTER MEDICAL LIMITED | 2022-11-28 |
| 05051471009585 | De Soutter Medical | DE SOUTTER MEDICAL LIMITED | 2022-11-28 |
| 05051471002623 | De Soutter Medical | DE SOUTTER MEDICAL LIMITED | 2022-11-28 |