KDC · Instrument, Surgical, Disposable
General, Plastic Surgery · 21 CFR 878.4800 · Class 1
Overview
| Product Code | KDC |
|---|---|
| Device Name | Instrument, Surgical, Disposable |
| 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 67)
Showing 20 most recent of 67 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K943229 | DISPOSABLE SURGICAL SCISSORS AND FORCEPS | Y.M.K. International Co., Ltd. | Aug 19, 1994 | SESE |
| K936226 | SURGIMED BREAST LOCALIZATION NEEDLE WIRE SET | Meadox Medicals, Div. Boston Scientific Corp. | Mar 7, 1994 | SESE |
| K920153 | THERMUFF BAG | Techstyles | Jul 1, 1992 | SESE |
| K920263 | MANUAL SURGICAL INSTRUMENTS | Phoenix Instruments Div. | May 6, 1992 | SESE |
| K915064 | DISPOSABLE CAUTERY ABRASIVE PAD | American Medical Mfg., Inc. | Mar 11, 1992 | SESE |
| K914960 | INSTRUMENT ORGANIZER | O.R. Concepts, Inc. | Feb 28, 1992 | SESE |
| K912834 | SHUR-GRIP | Inman Medical Corp. | Jul 26, 1991 | SESE |
| K910079 | DISPOSABLE INTRODUCER SHEATH | Applied Vascular Devices, Inc. | Feb 27, 1991 | SESE |
| K905240 | VESSELOOPS | Sparta Surgical Corp. | Feb 6, 1991 | SESE |
| K903649 | BRADLEY TENACULUM HOLDER | Marlo Surgical Technology | Nov 2, 1990 | SESE |
| K900566 | RICHARD-ALLAN VESSEL LOOPS | Richard-Allan Medical Ind., Inc. | May 3, 1990 | SESE |
| K896676 | KEY VASCULAR LOOPS | Key Surgical, Inc. | Feb 27, 1990 | SESE |
| K854901 | PACIFIC GRASPER | Euro-Med Intl. | May 2, 1986 | SESE |
| K854898 | ATLANTIC GRASPER | Euro-Med Intl. | May 2, 1986 | SESE |
| K854897 | MAX-I-GRASP | Euro-Med Intl. | May 2, 1986 | SESE |
| K854896 | HOOK SCISSOR | Euro-Med Intl. | May 2, 1986 | SESE |
| K854895 | BASKET FORCEP | Euro-Med Intl. | May 2, 1986 | SESE |
| K854894 | SPOON | Euro-Med Intl. | May 2, 1986 | SESE |
| K854890 | HOOK PROBE | Euro-Med Intl. | May 2, 1986 | SESE |
| K853597 | INSTRUMENT MAKAR DISPOSALBE LOOP | Instrument Makar, Inc. | Sep 23, 1985 | SESE |
Top Applicants
- Euro-Med Intl. — 7 clearances
- Instranetics, Inc. — 5 clearances
- Medcare Products — 4 clearances
- Omega-Med Intl., Inc. — 4 clearances
- Devon Industries, Inc. — 3 clearances
