GDX · Scalpel, One-Piece
General, Plastic Surgery · 21 CFR 878.4800 · Class 1
Overview
| Product Code | GDX |
|---|---|
| Device Name | Scalpel, One-Piece |
| 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 26)
Showing 20 most recent of 26 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K923689 | SURGISTAR BLADES | Surgistar, Inc. | Sep 9, 1992 | SESE |
| K921167 | ULTRABLADE | Micron Technology, Inc. | Jul 30, 1992 | SESE |
| K914086 | ICAN CYLINDRICAL SPONGES | Icn Pharmaceuticals, Inc. | Oct 9, 1991 | SESE |
| K904505 | CCI CORNEAL SCARIFIER | Buckman Co., Inc. | Apr 23, 1991 | SESE |
| K905380 | 1-CUT ACL GRAFT KNIFE | Depuy, Inc. | Dec 13, 1990 | SESE |
| K895682 | VESSEL LOOPS | Applied Medical Technologies | Oct 24, 1989 | SESE |
| K893033 | MINI-DIAMOND KNIFE | L.A.B. Instruments | May 26, 1989 | SESE |
| K880028 | OMED DISPOSABLE SCALPEL | Oxboro Medical Intl., Inc. | Jan 29, 1988 | SESE |
| K871894 | KCK INDUSTRIES' SURGICAL INSTRUMENTS | Kck Industries | Jun 23, 1987 | SESE |
| K863950 | P.S.I.-DISPOSABLE METAL HANDLE SURGEONS SCALPEL | Precision Surgical Industries, Inc. | Oct 24, 1986 | SESE |
| K863213 | KEISEI SCALPEL (STERILE AND NON-STERILE) | Keisei Medical Industrial Co., Ltd. | Sep 2, 1986 | SESE |
| K854857 | SCALPEL, ONE-PIECE, DISPOSABLE | Medelec Intl. Corp. | Dec 24, 1985 | SESE |
| K853103 | MCKNIFE | Medical Dimensions | Aug 6, 1985 | SESE |
| K851751 | 7-120, 7-130,7-140, 7-150,9-151 TO 168, 9-171 TO 1 | Artiberia | Jun 20, 1985 | SESE |
| K834541 | H.R. JAKOBI SURG. INSTRUMENTS #9-SEC.48 | Imm Enterprises , Ltd. | Jan 27, 1984 | SESE |
| K833467 | SURE-CUT | Diverse Technologies, Inc. | Jan 27, 1984 | SESE |
| K830745 | ADT DISPOSABLE SCALPEL W/STAINLESS STEEL | Lab Industries, Inc. | Apr 12, 1983 | SESE |
| K822893 | G.E.V. DISPOSABLE SCALPELS | Ascep, Inc. | Oct 22, 1982 | SESE |
| K822749 | PILLING DIAMOND KNIFE | Narco Scientific | Oct 6, 1982 | SESE |
| K820869 | DISPOSABLE #11 SCALPEL BLADE W/SHORT | Van-Tec, Inc. | May 5, 1982 | SESE |
Top Applicants
- Van-Tec, Inc. — 1 clearance
- Surgistar, Inc. — 1 clearance
- Precision Surgical Industries, Inc. — 1 clearance
- Oxboro Medical Intl., Inc. — 1 clearance
- Neonatal Corp. — 1 clearance
