GDO · Applier, Surgical, Clip
General, Plastic Surgery · 21 CFR 878.4800 · Class 1
Overview
| Product Code | GDO |
|---|---|
| Device Name | Applier, Surgical, Clip |
| 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 (14)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K926199 | UNICLIP SURGICAL CLIP APPLIER | Unisurge, Inc. | Apr 20, 1993 | SESE |
| K890941 | MODIFIED SUTURE DISP. ENDOSCOPIC SURGICAL CLIP APP | United States Surgical, A Division of Tyco Healthc | Apr 7, 1989 | SESE |
| K890159 | TOWEL CLIPS | Dhason Brothers, Inc. | Feb 3, 1989 | SESE |
| K890233 | SUTURE CLIP APPLIER/REMOVER | Kinetic Medical Products | Jan 27, 1989 | SESE |
| K820837 | DISPOSABLE MULTIPLE LIGATING CLIP | ETHICON, Inc. | May 28, 1982 | SESE |
| K812291 | ETHICON MULTIPLE LIGATING CLIP APPLIER | ETHICON, Inc. | Sep 11, 1981 | SESE |
| K792378 | HEMOSPENSER CARTRIDGE CAT. NO. 523500- | Edward Weck, Inc. | Dec 6, 1979 | SESE |
| K791845 | BAYONET HEIFETZ CLIP APPLIERS | Edward Weck, Inc. | Oct 17, 1979 | SESE |
| K790855 | SURGICAL DRAPE CLIP #201 | C. Intl. | Aug 3, 1979 | SESE |
| K791157 | 360 HEMOCLIP APPLIERS | Edward Weck, Inc. | Jun 27, 1979 | SESE |
| K790990 | REYNOLDS DOUBLE HEMOCLIP APPLIERS | Edward Weck, Inc. | Jun 5, 1979 | SESE |
| K772286 | FORCEPS, SUTURE, AUTO | Hartmann Group, Inc. | Dec 20, 1977 | SESE |
| K771412 | LIGACLIP MULTIPLE CLIP APPLIER | ETHICON, Inc. | Nov 28, 1977 | SESE |
| K771640 | SUTURE CLIP REMOVER | United States Surgical, A Division of Tyco Healthc | Sep 30, 1977 | SESE |
Top Applicants
- Edward Weck, Inc. — 4 clearances
- ETHICON, Inc. — 3 clearances
- United States Surgical, A Division of Tyco Healthc — 2 clearances
- Unisurge, Inc. — 1 clearance
- Kinetic Medical Products — 1 clearance
