GDZ · Handle, Scalpel
General, Plastic Surgery · 21 CFR 878.4800 · Class 1
Overview
| Product Code | GDZ |
|---|---|
| Device Name | Handle, Scalpel |
| 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.
Cleared Devices (16)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K091462 | SPECTRA MEDICAL SAFETY SCAPEL | Spectra, Inc. | Dec 15, 2009 | SESE |
| K890242 | SCALPEL HANDLE | Kinetic Medical Products | Jan 27, 1989 | SESE |
| K884512 | BEAVER(R) HANDLE | Bd Becton Dickinson Vacutainer Systems Preanalytic | Nov 17, 1988 | SESE |
| K863951 | P.S.I.-DISPOSABLE SCALPEL SURGEONS HANDLE | Precision Surgical Industries, Inc. | Oct 24, 1986 | SESE |
| K863808 | THE S. CORDERO STYLUS | S. Cordero Co. | Oct 14, 1986 | SESE |
| K863212 | KEISEI HANDLES FOR SURGICAL BLADES | Keisei Medical Industrial Co., Ltd. | Sep 2, 1986 | SESE |
| K854858 | SCALPEL HANDLE | Medelec Intl. Corp. | Dec 24, 1985 | SESE |
| K852735 | SCALPEL HANDLE #7 SS 410 OR 420 | The Huxley Instrument Corp. | Jul 15, 1985 | SESE |
| K852711 | SCALPEL HANDLE #3 SS 410 OR 420 | The Huxley Instrument Corp. | Jul 15, 1985 | SESE |
| K851750 | 7-103, 7-104, 7-107 SCALPEL HANDLES, #3 #4 #7 | Artiberia | Jun 20, 1985 | SESE |
| K852042 | BRIMFIELD CANNULATED BLADE HOLDER | Brimfield Scientific Instruments | Jun 11, 1985 | SESE |
| K812876 | SURGICAL PAWS | M-W Laboratories, Inc. | Nov 20, 1981 | SESE |
| K812814 | ZEE SURGICAL INSTRUMENTS | Zee Medical Products Co., Inc. | Nov 6, 1981 | SESE |
| K812070 | BORES* ADJUSTABLE BLADE HOLDER | Santa Barbara Medco, Inc. | Aug 18, 1981 | SESE |
| K810720 | I.M. SCALPEL HANDLE | Instrument Makar, Inc. | Apr 3, 1981 | SESE |
| K761035 | SURGICAL BLADE HANDLES | Parke-Davis Co. | Dec 21, 1976 | SESE |
Top Applicants
- The Huxley Instrument Corp. — 2 clearances
- Zee Medical Products Co., Inc. — 1 clearance
- Spectra, Inc. — 1 clearance
- Santa Barbara Medco, Inc. — 1 clearance
- S. Cordero Co. — 1 clearance
