EMF — Knife, Surgical Class I
FDA product code EMF covers "Knife, Surgical", a Class I medical device regulated under 21 CFR 878.4800. 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
- EMF
- Device Class
- Class I
- Regulation Number
- 878.4800
- Submission Type
- 510(k) Exempt
- Review Panel
- SU
- Medical Specialty
- General, Plastic Surgery
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K080133 | A.M. Surgical | MOUNTABLE ENDOSCOPIC BLADE | Mar 13, 2008 |
| K982142 | A.M. Surgical | MOUNTABLE ENDOSCOPIC KNIFE | Dec 30, 1998 |
| K890214 | Kinetic Medical Products | MICROSURGERY RAZOR BLADE HOLDER | Jan 27, 1989 |
| K890215 | Kinetic Medical Products | MICROSURGICAL SCARIFIER | Jan 27, 1989 |
| K890217 | Kinetic Medical Products | MICROSURGICAL KNIVES | Jan 27, 1989 |
| K880094 | Van-Tec | VAN-TEC ENDOPYELOTOMY KNIFE | Feb 29, 1988 |
| K863752 | Davis And Geck | VALTRAC (BAR) REMOVER DEVICE | Oct 24, 1986 |
| K863549 | Surgipath Medical Industries | REUSABLE/DISPOSABLE AUTOPSY KNIFE SET | Sep 30, 1986 |
| K861947 | Sharpoint | SURGICAL KNIFE | Jun 6, 1986 |
| K854891 | Euro-Med Intl | KNIFE | May 2, 1986 |
| K851784 | Artiberia | 27-210 PLASTER KNIFE (REINER) | Jun 20, 1985 |
| K843497 | Eder Instrument Co | SURGICAL KNIVES & PROBES | Oct 31, 1984 |
| K843371 | Downs Surgical | VALVOTOMY KNIFE | Oct 25, 1984 |
| K834197 | Imm Enterprises | JAKOBI SURG. INSTR- #11 38/39/45/46/67 | Jan 27, 1984 |
| K834184 | Imm Enterprises | H.R. JAKOBI SURG. INSTRUMENTS #11 38/67 | Jan 27, 1984 |
| K832368 | Devon Industries | CHANGING METHOD OF STERILITY RELEASE | Oct 31, 1983 |
| K821769 | Biological And Environmental Control Laboratories | MICROKNIFE | Sep 14, 1982 |
| K801585 | Precision Instruments | HESSBURG-BFRRON TREPHINE | Oct 3, 1980 |
| K791286 | Vista Medical Products | WECK MICROSURGICAL KNIFE | Jul 24, 1979 |
| K780989 | Nestor Engineering Associates | DEVIN-NESTOR SQUARE KNIFE | Oct 3, 1978 |