GEN · Forceps, General & Plastic Surgery
General, Plastic Surgery · 21 CFR 878.4800 · Class 1
Overview
| Product Code | GEN |
|---|---|
| Device Name | Forceps, 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.
Recent Cleared Devices (20 of 104)
Showing 20 most recent of 104 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K031828 | NATURALASE LP ND:YAG LASER | Focus Medical, LLC | Jul 17, 2003 | SESE |
| K953962 | FORCEPS | Biopsys Medical, Inc. | Sep 8, 1995 | SESE |
| K932385 | SUTURE REMOVING FORCEPS | Rocket of London, Ltd. | Aug 6, 1993 | SESE |
| K904723 | FORCEPS | Minto Research & Development, Inc. | Jul 26, 1991 | SESE |
| K911159 | PALPATION PROBE | Northgate Technologies, Inc. | Mar 29, 1991 | SESE |
| K900960 | GS-1500 CLAW FORCEP, 10MM | Solos Endoscopy, Inc. | Apr 18, 1990 | SESE |
| K900952 | GS-1200 GRASPING/EXTRACTING FORCEP, 10MM | Solos Endoscopy, Inc. | Apr 18, 1990 | SESE |
| K900951 | GS-7000 CLIP-APPLYING FORCEP, 10MM, MEDIUM CLIP | Solos Endoscopy, Inc. | Apr 18, 1990 | SESE |
| K900948 | GS-1002 GRASPING FORCEP, 5MM WITH RATCHET | Solos Endoscopy, Inc. | Apr 18, 1990 | SESE |
| K891896 | TISSUE FORCEPS, VARIOUS TYPES | Zinnanti Surgical Instruments, Inc. | Apr 12, 1989 | SESE |
| K891401 | HEMOSTATIC FORCEPS BRUNS.,GEMINI,SPENCER-WELL,KANT | Zinnanti Surgical Instruments, Inc. | Apr 6, 1989 | SESE |
| K891348 | CAMPION LASER FORCEPS | Simpson/Basye, Inc. | Mar 22, 1989 | SESE |
| K884514 | FORCEPS, TOWEL, BACKHAUS-TSK (BRAND) TOWEL | Gatewood and Associates, Ltd. | Nov 17, 1988 | SESE |
| K884181 | MANUAL SURGICAL INSTRUMENTS (SEVERAL MODELS) | Sales & Marketing Assoc. | Nov 10, 1988 | SESE |
| K884195 | GENERAL SURGICAL INSTRUMENTS (VARIOUS TYPES) | Mumtaz I. Malik | Oct 24, 1988 | SESE |
| K875319 | NSN #6515-00-690-3209 DEBAKEY TISSUE FORCEPS | I-Tech Industries, Inc. | Jan 22, 1988 | SESE |
| K874634 | NSN #6515-00-333-2400 ADSON DRESSING FORCEPS | I-Tech Industries, Inc. | Dec 2, 1987 | SESE |
| K873978 | DISPOSABLE BIPOLAR FORCEPS | E.M. Adams | Nov 23, 1987 | SESE |
| K872991 | MICRINS FORCEPS 2010 | Micrins Surgical, Inc. | Aug 17, 1987 | SESE |
| K872271 | VARIOUS SIZES & STYLES OF MONOPOLAR FORCEPS | New England Surgical Instrument Corp. | Jun 26, 1987 | SESE |
Top Applicants
- Conphar, Inc. — 14 clearances
- The Huxley Instrument Corp. — 8 clearances
- Mill-Rose Laboratory — 6 clearances
- Artiberia — 6 clearances
- Edward Weck, Inc. — 5 clearances
