GET — Motor, Surgical Instrument, Pneumatic Powered Class I
FDA product code GET covers "Motor, Surgical Instrument, Pneumatic 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
- GET
- 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 |
|---|---|---|---|
| K960473 | aesculap | AESCULAP POWER SYSTEM HANDPIECE | March 7, 1996 |
| K955174 | sodem diffusion | SODEM HIGH SPEED SYSTEM FOR NEUROSURGERY & MEDIAN STYERNOTOMY | January 22, 1996 |
| K942987 | surgical dynamics | NUCLEOTOME L KIT | October 30, 1995 |
| K954076 | midas rex pneumatic tools | MIDAS REX DRILL ATTACHMENTS & TWIST DRILLS | October 18, 1995 |
| K953433 | midas rex pneumatic tools | MIDAS REX TELESCOPING SYSTEM | September 15, 1995 |
| K953432 | midas rex pneumatic tools | ROTATING, FIXED FOOTED, FIXED SHIELD ATTACHMENTS, DISSECTING TOOLS | September 14, 1995 |
| K952463 | midas rex pneumatic tools | GS & GS20 SURGICAL TOOL SYSTEM | July 17, 1995 |
| K952300 | midas rex pneumatic tools | MIDAS REX MOTORS (MIDAS I, II & CONVERTIBLE MODELS) | May 26, 1995 |
| K914753 | united states surgical, a division of tyco healthc | AUTO SUTURE(R) ARTICULATING ENDOSCOPIC CLAMP | June 11, 1992 |
| K910071 | sen tech medical | PORTA GAS COMPRESSED GAS CYLINDER CART | March 22, 1991 |
| K904578 | united states surgical, a division of tyco healthc | MODIFICATION AUTO SUTURE(R) ENDOSCOPIC CLAMP | October 30, 1990 |
| K885066 | surgical dynamics | HEMATOME SYSTEM | May 1, 1989 |
| K872951 | american silk sutures | AMERICAN BRAIN RETRACTOR COVER | September 16, 1987 |
| K863447 | stryker | STRYKER ORTHOPOWER 90 & ORTHOPOWER 90 SYSTEM II | September 29, 1986 |
| K843498 | eder instrument co | BIPOLAR SUCTION ELECTRODE | December 14, 1984 |
| K840370 | suncoast medical manufacturers | SURG-A-STAT VASECTOMY TIP | July 23, 1984 |
| K833187 | amsco | HALL OSTEON | October 31, 1983 |
| K832187 | amsco | HALL OSCILLATOR | August 12, 1983 |
| K832188 | amsco | HALL RECIPROCATOR | August 12, 1983 |
| K832186 | amsco | HALL DRILL/REAMER | August 12, 1983 |