EMF · Knife, Surgical
General, Plastic Surgery · 21 CFR 878.4800 · Class 1
Overview
| Product Code | EMF |
|---|---|
| Device Name | Knife, Surgical |
| Regulation | 21 CFR 878.4800 |
| Device Class | Class 1 |
| Review Panel | General, Plastic Surgery |
Identification
A manual surgical instrument for general use is a nonpowered, hand-held, or hand manipulated device, either reusable or disposable, intended to be used in various general surgical procedures. The device includes the applicator, clip applier, biopsy brush, manual dermabrasion brush, scrub brush, cannula, ligature carrier, chisel, clamp, contractor, curette, cutter, dissector, elevator, skin graft expander, file, forceps, gouge, instrument guide, needle guide, hammer, hemostat, amputation hook, ligature passing and knot-tying instrument, knife, mallet, disposable or reusable aspiration and injection needle, disposable or reusable suturing needle, osteotome, pliers, rasp, retainer, retractor, saw, scalpel blade, scalpel handle, one-piece scalpel, snare, spatula, stapler, disposable or reusable stripper, stylet, suturing apparatus for the stomach and intestine, measuring tape, and calipers. A surgical instrument that has specialized uses in a specific medical specialty is classified in separate regulations in parts 868 through 892 of this chapter.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.
Recent Cleared Devices (20 of 21)
Showing 20 most recent of 21 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K080133 | MOUNTABLE ENDOSCOPIC BLADE | A.M. Surgical, Inc. | Mar 13, 2008 | SESE |
| K982142 | MOUNTABLE ENDOSCOPIC KNIFE | A.M. Surgical, Inc. | Dec 30, 1998 | SESE |
| K890217 | MICROSURGICAL KNIVES | Kinetic Medical Products | Jan 27, 1989 | SESE |
| K890215 | MICROSURGICAL SCARIFIER | Kinetic Medical Products | Jan 27, 1989 | SESE |
| K890214 | MICROSURGERY RAZOR BLADE HOLDER | Kinetic Medical Products | Jan 27, 1989 | SESE |
| K880094 | VAN-TEC ENDOPYELOTOMY KNIFE | Van-Tec, Inc. | Feb 29, 1988 | SESE |
| K863752 | VALTRAC (BAR) REMOVER DEVICE | Davis & Geck, Inc. | Oct 24, 1986 | SESE |
| K863549 | REUSABLE/DISPOSABLE AUTOPSY KNIFE SET | Surgipath Medical Industries, Inc. | Sep 30, 1986 | SESE |
| K861947 | SURGICAL KNIFE | Sharpoint, Inc. | Jun 6, 1986 | SESE |
| K854891 | KNIFE | Euro-Med Intl. | May 2, 1986 | SESE |
| K851784 | 27-210 PLASTER KNIFE (REINER) | Artiberia | Jun 20, 1985 | SESE |
| K843497 | SURGICAL KNIVES & PROBES | Eder Instrument Co, Inc. | Oct 31, 1984 | SESE |
| K843371 | VALVOTOMY KNIFE | Downs Surgical , Ltd. | Oct 25, 1984 | SESE |
| K834197 | JAKOBI SURG. INSTR- #11 38/39/45/46/67 | Imm Enterprises , Ltd. | Jan 27, 1984 | SESE |
| K834184 | H.R. JAKOBI SURG. INSTRUMENTS #11 38/67 | Imm Enterprises , Ltd. | Jan 27, 1984 | SESE |
| K832368 | CHANGING METHOD OF STERILITY RELEASE | Devon Industries, Inc. | Oct 31, 1983 | SESE |
| K821769 | MICROKNIFE | Biological & Environmental Control Laboratories | Sep 14, 1982 | SESE |
| K801585 | HESSBURG-BFRRON TREPHINE | Precision Instruments, Inc. | Oct 3, 1980 | SESE |
| K791286 | WECK MICROSURGICAL KNIFE | Vista Medical Products, Inc. | Jul 24, 1979 | SESE |
| K780991 | PARALLEL BLADE MARKER | Nestor Engineering Associates, Inc. | Oct 3, 1978 | SESE |
Top Applicants
- Kinetic Medical Products — 3 clearances
- Nestor Engineering Associates, Inc. — 2 clearances
- Imm Enterprises , Ltd. — 2 clearances
- A.M. Surgical, Inc. — 2 clearances
- Vista Medical Products, Inc. — 1 clearance
