EMF
21 FDA 510(k) clearances · Product code
56 daysmedian time to decision
111 days90th percentile
21clearances measured
FDA profile
- Official device name
- Knife, Surgical
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4800
- Medical specialty
- General, Plastic Surgery
- Adverse events (MAUDE)
- 2001: 2 · 2003: 2 · 2004: 2 · 2005: 3 · 2010: 4 · 2011: 5
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| MOUNTABLE ENDOSCOPIC BLADE (K080133) | A.M. Surgical, Inc. | 2008-03-13 |
| MOUNTABLE ENDOSCOPIC KNIFE (K982142) | A.M. Surgical, Inc. | 1998-12-30 |
| MICROSURGICAL KNIVES (K890217) | Kinetic Medical Products | 1989-01-27 |
| MICROSURGICAL SCARIFIER (K890215) | Kinetic Medical Products | 1989-01-27 |
| MICROSURGERY RAZOR BLADE HOLDER (K890214) | Kinetic Medical Products | 1989-01-27 |
| VAN-TEC ENDOPYELOTOMY KNIFE (K880094) | Van-Tec, Inc. | 1988-02-29 |
| VALTRAC (BAR) REMOVER DEVICE (K863752) | Davis & Geck, Inc. | 1986-10-24 |
| REUSABLE/DISPOSABLE AUTOPSY KNIFE SET (K863549) | Surgipath Medical Industries, Inc. | 1986-09-30 |
| SURGICAL KNIFE (K861947) | Sharpoint, Inc. | 1986-06-06 |
| KNIFE (K854891) | Euro-Med Intl. | 1986-05-02 |
| 27-210 PLASTER KNIFE (REINER) (K851784) | Artiberia | 1985-06-20 |
| SURGICAL KNIVES & PROBES (K843497) | Eder Instrument Co, Inc. | 1984-10-31 |
| VALVOTOMY KNIFE (K843371) | Downs Surgical , Ltd. | 1984-10-25 |
| JAKOBI SURG. INSTR- #11 38/39/45/46/67 (K834197) | Imm Enterprises , Ltd. | 1984-01-27 |
| H.R. JAKOBI SURG. INSTRUMENTS #11 38/67 (K834184) | Imm Enterprises , Ltd. | 1984-01-27 |
| CHANGING METHOD OF STERILITY RELEASE (K832368) | Devon Industries, Inc. | 1983-10-31 |
| MICROKNIFE (K821769) | Biological & Environmental Control Laboratories | 1982-09-14 |
| HESSBURG-BFRRON TREPHINE (K801585) | Precision Instruments, Inc. | 1980-10-03 |
| WECK MICROSURGICAL KNIFE (K791286) | Vista Medical Products, Inc. | 1979-07-24 |
| PARALLEL BLADE MARKER (K780991) | Nestor Engineering Associates, Inc. | 1978-10-03 |
| DEVIN-NESTOR SQUARE KNIFE (K780989) | Nestor Engineering Associates, Inc. | 1978-10-03 |
Track EMF automatically
Every clearance here is in the API, with alerts when new ones post.