GEY — Motor, Surgical Instrument, Ac-Powered Class I
FDA product code GEY covers "Motor, Surgical Instrument, Ac-Powered", a Class I medical device regulated under 21 CFR 878.4820. Submissions are reviewed by the General, Plastic Surgery panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- GEY
- Device Class
- Class I
- Regulation Number
- 878.4820
- Submission Type
- Review Panel
- SU
- Medical Specialty
- General, Plastic Surgery
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K050519 | linvatec | ADVANCED TURBO DRIVE SYSTEM | May 17, 2005 |
| K020621 | arthrocare | ARTHROCARE CONTROLLER; ARTHROCARE CABLE; FOOT CONTROL; POWER CORD; WANDS | March 28, 2002 |
| K012738 | depuyacromed | SYMPHONY GRAFT DELIVERY SYSTEM (GDS) | November 14, 2001 |
| K972308 | mednext | MEDNEXT 1000 DRILL | August 20, 1997 |
| K971941 | boyd industries | AQUA SPRAY | August 14, 1997 |
| K971782 | biomedical ent | BONE AND MARROW COLLECTION SYSTEM KIT | July 29, 1997 |
| K971268 | biomedical international | BONE & MARROW CLLECTION SYSTEM | July 3, 1997 |
| K964252 | buckman co | ORTHOCHUCK | May 27, 1997 |
| K970530 | anspach effort | ANSPACH LUBRICATING SYSTEM II | May 5, 1997 |
| K964073 | biomedical ent | BME BONE DRILL BITS | November 14, 1996 |
| K962789 | smith and nephew endoscopy | SURGICAL KIT-ACUFEX MOSAICPLASTY SYSTEM | August 14, 1996 |
| K961901 | biomedical ent | BONE & MARROW COLLECTION SYSTEM | August 6, 1996 |
| K954470 | w.o.m. world of medicine | SURGIMOTOR | December 8, 1995 |
| K951773 | darco intl | PODOSPRAY DRILL SYSTEM | October 26, 1995 |
| K952008 | karl storz endoscopy-america | KARL STORZ DRILL | July 26, 1995 |
| K951118 | 3m | 3M MAXI-DRIVER II ELECTRIC SYSTEM | July 6, 1995 |
| K940535 | anspach effort | AUTO LUBE SYSTEM | March 21, 1994 |
| K934172 | acro-poly | ACRO-POLY, INC. HANDPIECE/ANGLEHEAD ACCESSORIES FOR SURGICAL INSTUMENTS | October 27, 1993 |
| K932700 | linvatec | CUTO(TM) TISSUE MORCELLATION SYSTEM | October 15, 1993 |
| K925360 | elekta instruments | ES-100 POWER SYSTEM, ES-100 SERIES | September 7, 1993 |