GEY · Motor, Surgical Instrument, Ac-Powered
General, Plastic Surgery · 21 CFR 878.4820 · Class 1
Overview
| Product Code | GEY |
|---|---|
| Device Name | Motor, Surgical Instrument, Ac-Powered |
| Regulation | 21 CFR 878.4820 |
| Device Class | Class 1 |
| Review Panel | General, Plastic Surgery |
Identification
Surgical instrument motors and accessories are AC-powered, battery-powered, or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver, and saw blade.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.
Recent Cleared Devices (20 of 41)
Showing 20 most recent of 41 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K050519 | ADVANCED TURBO DRIVE SYSTEM | Linvatec Corp. | May 17, 2005 | SESE |
| K020621 | ARTHROCARE CONTROLLER; ARTHROCARE CABLE; FOOT CONTROL; POWER CORD; WANDS | Arthrocare Corp. | Mar 28, 2002 | SESE |
| K012738 | SYMPHONY GRAFT DELIVERY SYSTEM (GDS) | Depuyacromed | Nov 14, 2001 | SESE |
| K972308 | MEDNEXT 1000 DRILL | Mednext, Inc. | Aug 20, 1997 | SESE |
| K971941 | AQUA SPRAY | Boyd Industries, Inc. | Aug 14, 1997 | SESE |
| K971782 | BONE AND MARROW COLLECTION SYSTEM KIT | Biomedical Ent., Inc. | Jul 29, 1997 | SESE |
| K971268 | BONE & MARROW CLLECTION SYSTEM | Biomedical International Corp. | Jul 3, 1997 | SESE |
| K964252 | ORTHOCHUCK | Buckman Co., Inc. | May 27, 1997 | SESE |
| K970530 | ANSPACH LUBRICATING SYSTEM II | The Anspach Effort, Inc. | May 5, 1997 | SESE |
| K964073 | BME BONE DRILL BITS | Biomedical Ent., Inc. | Nov 14, 1996 | SESE |
| K962789 | SURGICAL KIT-ACUFEX MOSAICPLASTY SYSTEM | Smith & Nephew Endoscopy, Inc. | Aug 14, 1996 | SESE |
| K961901 | BONE & MARROW COLLECTION SYSTEM | Biomedical Ent., Inc. | Aug 6, 1996 | SESE |
| K954470 | SURGIMOTOR | W.O.M. World of Medicine GmbH | Dec 8, 1995 | SESE |
| K951773 | PODOSPRAY DRILL SYSTEM | Darco Intl., Inc. | Oct 26, 1995 | SESE |
| K952008 | KARL STORZ DRILL | KARL STORZ Endoscopy-America, Inc. | Jul 26, 1995 | SESE |
| K951118 | 3M MAXI-DRIVER II ELECTRIC SYSTEM | 3M Company | Jul 6, 1995 | SESE |
| K940535 | AUTO LUBE SYSTEM | The Anspach Effort, Inc. | Mar 21, 1994 | SESE |
| K934172 | ACRO-POLY, INC. HANDPIECE/ANGLEHEAD ACCESSORIES FOR SURGICAL INSTUMENTS | Acro-Poly, Inc. | Oct 27, 1993 | SESE |
| K932700 | CUTO(TM) TISSUE MORCELLATION SYSTEM | Linvatec Corp. | Oct 15, 1993 | SESE |
| K925360 | ES-100 POWER SYSTEM, ES-100 SERIES | Elekta Instruments, Inc. | Sep 7, 1993 | SESE |
Top Applicants
- American Surgical Laser, Inc. — 3 clearances
- Biomedical Ent., Inc. — 3 clearances
- Micro Surgical Instruments Corp. — 3 clearances
- The Anspach Effort, Inc. — 3 clearances
- Black & Decker(Tm) — 2 clearances
