GDI · Dissector, Surgical, General & Plastic Surgery
General, Plastic Surgery · 21 CFR 878.4800 · Class 1
Overview
| Product Code | GDI |
|---|---|
| Device Name | Dissector, Surgical, General & Plastic Surgery |
| 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 (7)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K896383 | DISPOSABLE EXTERNAL CLAMPS | Galenica Enterprises, Inc. | Dec 6, 1989 | SESE |
| K850288 | HEPATIC PARENCHYMAL SUCTION DISSECTOR | Beecher Medical Diagnostic Instrumentation | Mar 18, 1985 | SESE |
| K831912 | ROUND-BEEHIVE- DISSECTORS 3/8 | Ormed Mfg., Inc. | Oct 31, 1983 | SESE |
| K822569 | TYMPANOPLASTY & SKIN DISSECTORS | Kelleher Corp. | Oct 6, 1982 | SESE |
| K803292 | FIELD SUCTION DISSECTOR | V. Mueller O.V. Baxter Healthcare Corp. | Jan 29, 1981 | SESE |
| K791870 | DISPOSABLE SPECIALITY SPONGES | Carwild Corp. | Nov 5, 1979 | SESE |
| K791703 | TEW BYPASS INSTRUMENTS & DISSECTING KIT | Edward Weck, Inc. | Oct 4, 1979 | SESE |
Top Applicants
- V. Mueller O.V. Baxter Healthcare Corp. — 1 clearance
- Ormed Mfg., Inc. — 1 clearance
- Kelleher Corp. — 1 clearance
- Galenica Enterprises, Inc. — 1 clearance
- Edward Weck, Inc. — 1 clearance
