GET · Motor, Surgical Instrument, Pneumatic Powered
General, Plastic Surgery · 21 CFR 878.4820 · Class 1
Overview
| Product Code | GET |
|---|---|
| Device Name | Motor, Surgical Instrument, Pneumatic 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.
Cleared Devices (23)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K960473 | AESCULAP POWER SYSTEM HANDPIECE | Aesculap, Inc. | Mar 7, 1996 | SESE |
| K955174 | SODEM HIGH SPEED SYSTEM FOR NEUROSURGERY & MEDIAN STYERNOTOMY | Sodem Diffusion SA | Jan 22, 1996 | SESE |
| K942987 | NUCLEOTOME L KIT | Surgical Dynamics, Inc. | Oct 30, 1995 | SESE |
| K954076 | MIDAS REX DRILL ATTACHMENTS & TWIST DRILLS | Midas Rex Pneumatic Tools, Inc. | Oct 18, 1995 | SESE |
| K953433 | MIDAS REX TELESCOPING SYSTEM | Midas Rex Pneumatic Tools, Inc. | Sep 15, 1995 | SESE |
| K953432 | ROTATING, FIXED FOOTED, FIXED SHIELD ATTACHMENTS, DISSECTING TOOLS | Midas Rex Pneumatic Tools, Inc. | Sep 14, 1995 | SESE |
| K952463 | GS & GS20 SURGICAL TOOL SYSTEM | Midas Rex Pneumatic Tools, Inc. | Jul 17, 1995 | SESE |
| K952300 | MIDAS REX MOTORS (MIDAS I, II & CONVERTIBLE MODELS) | Midas Rex Pneumatic Tools, Inc. | May 26, 1995 | SESE |
| K914753 | AUTO SUTURE(R) ARTICULATING ENDOSCOPIC CLAMP | United States Surgical, A Division of Tyco Healthc | Jun 11, 1992 | SESE |
| K910071 | PORTA GAS COMPRESSED GAS CYLINDER CART | Sen Tech Medical Corp. | Mar 22, 1991 | SESE |
| K904578 | MODIFICATION AUTO SUTURE(R) ENDOSCOPIC CLAMP | United States Surgical, A Division of Tyco Healthc | Oct 30, 1990 | SESE |
| K885066 | HEMATOME SYSTEM | Surgical Dynamics, Inc. | May 1, 1989 | SESE |
| K872951 | AMERICAN BRAIN RETRACTOR COVER | American Silk Sutures, Inc. | Sep 16, 1987 | SESE |
| K863447 | STRYKER ORTHOPOWER 90 & ORTHOPOWER 90 SYSTEM II | Stryker Corp. | Sep 29, 1986 | SESE |
| K843498 | BIPOLAR SUCTION ELECTRODE | Eder Instrument Co, Inc. | Dec 14, 1984 | SESE |
| K840370 | SURG-A-STAT VASECTOMY TIP | Suncoast Medical Manufacturers, Inc. | Jul 23, 1984 | SESE |
| K833187 | HALL OSTEON | Amsco Co. | Oct 31, 1983 | SESE |
| K832188 | HALL RECIPROCATOR | Amsco Co. | Aug 12, 1983 | SESE |
| K832187 | HALL OSCILLATOR | Amsco Co. | Aug 12, 1983 | SESE |
| K832186 | HALL DRILL/REAMER | Amsco Co. | Aug 12, 1983 | SESE |
| K831675 | TWIST LOCK DRILL 1120 | Micro-Aire Surgical Instruments, Inc. | Jun 30, 1983 | SESE |
| K800382 | CLEAR-VIEW MIRROR WARMER | Surgical Mechanical Research, Inc. | May 14, 1980 | SESE |
| K790195 | FOOT VALVE | American Safety | Feb 26, 1979 | SESE |
Top Applicants
- Midas Rex Pneumatic Tools, Inc. — 5 clearances
- Amsco Co. — 4 clearances
- United States Surgical, A Division of Tyco Healthc — 2 clearances
- Surgical Dynamics, Inc. — 2 clearances
- Surgical Mechanical Research, Inc. — 1 clearance
