Product code GET
- Device name
- Motor, Surgical Instrument, Pneumatic 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 |
|---|---|---|---|
| K960473 | AESCULAP POWER SYSTEM HANDPIECE | Aesculap, Inc. | 1996-03-07 |
| K955174 | SODEM HIGH SPEED SYSTEM FOR NEUROSURGERY & MEDIAN STYERNOTOMY | Sodem Diffusion SA | 1996-01-22 |
| K942987 | NUCLEOTOME L KIT | Surgical Dynamics, Inc. | 1995-10-30 |
| K954076 | MIDAS REX DRILL ATTACHMENTS & TWIST DRILLS | Midas Rex Pneumatic Tools, Inc. | 1995-10-18 |
| K953433 | MIDAS REX TELESCOPING SYSTEM | Midas Rex Pneumatic Tools, Inc. | 1995-09-15 |
| K953432 | ROTATING, FIXED FOOTED, FIXED SHIELD ATTACHMENTS, DISSECTING TOOLS | Midas Rex Pneumatic Tools, Inc. | 1995-09-14 |
| K952463 | GS & GS20 SURGICAL TOOL SYSTEM | Midas Rex Pneumatic Tools, Inc. | 1995-07-17 |
| K952300 | MIDAS REX MOTORS (MIDAS I, II & CONVERTIBLE MODELS) | Midas Rex Pneumatic Tools, Inc. | 1995-05-26 |
| K914753 | AUTO SUTURE(R) ARTICULATING ENDOSCOPIC CLAMP | United States Surgical, A Division of Tyco Healthc | 1992-06-11 |
| K910071 | PORTA GAS COMPRESSED GAS CYLINDER CART | Sen Tech Medical Corp. | 1991-03-22 |
| K904578 | MODIFICATION AUTO SUTURE(R) ENDOSCOPIC CLAMP | United States Surgical, A Division of Tyco Healthc | 1990-10-30 |
| K885066 | HEMATOME SYSTEM | Surgical Dynamics, Inc. | 1989-05-01 |
| K872951 | AMERICAN BRAIN RETRACTOR COVER | American Silk Sutures, Inc. | 1987-09-16 |
| K863447 | STRYKER ORTHOPOWER 90 & ORTHOPOWER 90 SYSTEM II | Stryker Corp. | 1986-09-29 |
| K843498 | BIPOLAR SUCTION ELECTRODE | Eder Instrument Co, Inc. | 1984-12-14 |
| K840370 | SURG-A-STAT VASECTOMY TIP | Suncoast Medical Manufacturers, Inc. | 1984-07-23 |
| K833187 | HALL OSTEON | Amsco Co. | 1983-10-31 |
| K832188 | HALL RECIPROCATOR | Amsco Co. | 1983-08-12 |
| K832187 | HALL OSCILLATOR | Amsco Co. | 1983-08-12 |
| K832186 | HALL DRILL/REAMER | Amsco Co. | 1983-08-12 |
| K831675 | TWIST LOCK DRILL 1120 | Micro-Aire Surgical Instruments, Inc. | 1983-06-30 |
| K800382 | CLEAR-VIEW MIRROR WARMER | Surgical Mechanical Research, Inc. | 1980-05-14 |
| K790195 | FOOT VALVE | American Safety | 1979-02-26 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10845854022986 | CONMED | Conmed Corporation | 2020-11-28 |
| 10845854023204 | HALL OSTEON | Conmed Corporation | 2020-11-28 |
| 10845854023587 | NA | Conmed Corporation | 2020-11-28 |
| 10845854012338 | CONMED | Conmed Corporation | 2020-09-24 |
| 20845854044923 | HALL OSTEON | Conmed Corporation | 2020-09-24 |
| 10845854033180 | SMARTGUARD MICRO100 | Conmed Corporation | 2020-09-24 |
| 10845854023969 | ULTRAPOWER | Conmed Corporation | 2020-09-24 |
| 10845854023952 | ULTRAPOWER | Conmed Corporation | 2020-09-24 |
| 10845854023938 | ULTRAPOWER | Conmed Corporation | 2020-09-24 |
| 10845854023921 | ULTRAPOWER | Conmed Corporation | 2020-09-24 |
| 10845854023914 | ULTRAPOWER | Conmed Corporation | 2020-09-24 |
| 10845854023891 | ULTRAPOWER | Conmed Corporation | 2020-09-24 |
| 10845854023884 | ULTRAPOWER | Conmed Corporation | 2020-09-24 |
| 10845854023860 | ULTRAPOWER | Conmed Corporation | 2020-09-24 |
| 10845854004289 | CONMED | Conmed Corporation | 2020-09-24 |
| 10845854018996 | CONMED | Conmed Corporation | 2020-09-24 |
| 10845854022962 | NA | Conmed Corporation | 2020-09-24 |
| 10845854023815 | ULTRAPOWER | Conmed Corporation | 2020-09-24 |
| 10845854023839 | ULTRAPOWER | Conmed Corporation | 2020-09-24 |
| 10845854023846 | ULTRAPOWER | Conmed Corporation | 2020-09-24 |
| 10845854023853 | ULTRAPOWER | Conmed Corporation | 2020-09-24 |
| 10845854023877 | ULTRAPOWER | Conmed Corporation | 2020-09-24 |
| 10845854023990 | ULTRAPOWER | Conmed Corporation | 2020-09-16 |
| 30845854023208 | HALL OSTEON | Conmed Corporation | 2020-09-02 |
| 10884523000788 | Endo Lung | Covidien LP | 2018-08-18 |
| 10884523000665 | Endo Dissect | Covidien LP | 2018-08-10 |
| 10884523000702 | Endo Dissect | Covidien LP | 2018-08-10 |
| 10884523000740 | Endo Dissect | Covidien LP | 2018-08-10 |
| 10884523000795 | Endo Babcock | Covidien LP | 2018-08-10 |
| 10884523000818 | Endo Grasp | Covidien LP | 2018-08-10 |