HKP — Instrument, Vitreous Aspiration And Cutting, Battery-Powered Class II
FDA product code HKP covers "Instrument, Vitreous Aspiration And Cutting, Battery-Powered", a Class II medical device regulated under 21 CFR 886.4150. Submissions are reviewed by the Ophthalmic panel. At least 16 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- HKP
- Device Class
- Class II
- Regulation Number
- 886.4150
- Submission Type
- Review Panel
- OP
- Medical Specialty
- Ophthalmic
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K952558 | aaron medical industries | AARON VAC 2 | March 19, 1997 |
| K950056 | grieshaber and | THE GRIESHABER AXIAL CUTTER | May 5, 1995 |
| K950287 | medical instrument development laboratories | UNIVIT PROBE | April 10, 1995 |
| K896622 | visitec | VISITEC VITRECTOMY UNIT | April 4, 1990 |
| K890595 | mentor o and o | MENTOR ANTERIOR SEGMENT VITRECTOR | April 17, 1989 |
| K832074 | coopervision | CAVITRON/KELMAN PHACO-EMULSIFIER ASPIRA | August 1, 1983 |
| K822599 | frigitronics of connecticut | KEATES I/A SYSTEM FRIGITRONICS 4000 | October 6, 1982 |
| K813273 | optical micro systems | EMERGENCY POWER PAC (EMPAC) | December 31, 1981 |
| K810152 | temporaty surgical systems | X-VEE | March 17, 1981 |
| K801231 | coburn optical ind | EYE-VAC | July 21, 1980 |
| K791898 | cooper medical devices | OCUTOME MODEL 8000 | October 30, 1979 |
| K791000 | concept | VITREOUS SUCTION/CUTTER | September 4, 1979 |
| K790893 | varian assoc | STAT | August 28, 1979 |
| K780852 | varian assoc | CLINITEX VIS-X ASPIRATING ACCESSORY | November 3, 1978 |
| K761353 | concept | VITEROUS SUCTION CUTTER | January 5, 1977 |
| K760684 | varian assoc | VISC X-VITREOUS ASPIRATING & CUT. INSTR | October 5, 1976 |