GDJ · Clamp, Surgical, General & Plastic Surgery
General, Plastic Surgery · 21 CFR 878.4800 · Class 1
Overview
| Product Code | GDJ |
|---|---|
| Device Name | Clamp, 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.
Recent Cleared Devices (20 of 32)
Showing 20 most recent of 32 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K153358 | Standard Clamp | Standard Bariatrics | May 2, 2016 | SESE |
| K930315 | THORACIC CLAMPS: SAROT, KANTOWITZ AND LAWRENCE | Thomasville Medical Assoc. | Feb 4, 1994 | SESE |
| K924223 | MAR-MED LIVER STRAP | Mar-Med Co. | Mar 18, 1993 | SESE |
| K922659 | GENERAL SURGERY CLAMP AND NEEDLE HOLDER | Miltex Instrument Co. | Jul 21, 1992 | SESE |
| K914913 | GRICE FOOT PEDAL CONTROL/REDDICK IRRI/ASPIR SYST | Ideal Medical, Inc. | Dec 31, 1991 | SESE |
| K900956 | GS-7100 CHOLANGIOGRAM CLAMP, 5MM | Solos Endoscopy, Inc. | Apr 18, 1990 | SESE |
| K901107 | MODIFIED AUTO SUTURE PURSTRING DISP. AUTOMATIC | United States Surgical, A Division of Tyco Healthc | Apr 9, 1990 | SESE |
| K895726 | VESSEL OCCLUDER | Applied Medical Technologies | Oct 24, 1989 | SESE |
| K895591 | SILICONE INSTRUMENT SHODS | Key Surgical, Inc. | Oct 20, 1989 | SESE |
| K882169 | SURGICAL DUCT CLAMP (VINE) | Henley Intl. | Jun 17, 1988 | SESE |
| K881741 | STUART LEE CLIP | Stuart-Lee, Inc. | Jun 3, 1988 | SESE |
| K881084 | UTILITY CLAMP | Med-Dex Intl. | Mar 25, 1988 | SESE |
| K874428 | AUTO SUTURE PURSE STRING APPLIER* | United States Surgical, A Division of Tyco Healthc | Dec 2, 1987 | SESE |
| K855144 | TOURIQUET KIT WITH SNARE | Dlp, Inc. | Feb 5, 1986 | SESE |
| K853583 | MODERN MEDICAL PRODUCTS TOWEL CLAMP | Modern Medical Products | Sep 16, 1985 | SESE |
| K852724 | BACKHAUS TOWEL CLAMP, 5-1/2 + SS 410 OR 420 | The Huxley Instrument Corp. | Jul 15, 1985 | SESE |
| K851774 | 17-900 TO 17-980 VARIOUS TOWEL CLAMPS | Artiberia | Jun 20, 1985 | SESE |
| K843816 | TAL-CLIP | Talboy, Inc. | Oct 31, 1984 | SESE |
| K812388 | SURGICAL PAWS | Berkeley Medevices | Nov 16, 1981 | SESE |
| K801660 | PROXIMATE * PSD PURSE-STRING DEVICE | ETHICON, Inc. | Aug 13, 1980 | SESE |
Top Applicants
- Edward Weck, Inc. — 5 clearances
- Conphar, Inc. — 2 clearances
- Med General — 2 clearances
- United States Surgical, A Division of Tyco Healthc — 2 clearances
- Applied Medical Technologies — 1 clearance
