LRW · Scissors, General, Surgical
General, Plastic Surgery · 21 CFR 878.4800 · Class 1
Overview
| Product Code | LRW |
|---|---|
| Device Name | Scissors, General, Surgical |
| 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 (18 of 18)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K911158 | MICRO SCISSORS, 5MM CURVE MICRO SCISSORS, 5MM | Northgate Technologies, Inc. | Mar 29, 1991 | SESE |
| K902828 | SUTURE REMOVAL TRAY | Orion Life Systems, Inc. | Aug 8, 1990 | SEKD |
| K900957 | GS-2100 HOOK SUTURE SCISSOR, 5MM | Solos Endoscopy, Inc. | Apr 18, 1990 | SESE |
| K900950 | GS-2000 MICRO SCISSOR, CURVED LEFT, 5MM | Solos Endoscopy, Inc. | Apr 18, 1990 | SESE |
| K892823 | PLASTER CUTTING SCISSORS | The South India Surgical Co. Pvt. , Ltd. | May 25, 1989 | SESE |
| K891889 | OLIVECORONA SCISSORS | Zinnanti Surgical Instruments, Inc. | Apr 12, 1989 | SESE |
| K891886 | SCISSORS, VARIOUS TYPES | Zinnanti Surgical Instruments, Inc. | Apr 12, 1989 | SESE |
| K891203 | SCISSORS: THOREK, JORGENSEN, FINOCHIETTO | Zinnanti Surgical Instruments, Inc. | Apr 6, 1989 | SESE |
| K891200 | RIBBON TYPE SCISSORS: TENOTOMY,IRIS,EYE,STRABISMUS | Zinnanti Surgical Instruments, Inc. | Apr 6, 1989 | SESE |
| K890235 | DRESSING SCISSORS | Kinetic Medical Products | Feb 3, 1989 | SESE |
| K890170 | SCISSORS | Dhason Brothers, Inc. | Feb 3, 1989 | SESE |
| K890264 | STRABISMUS SCISSORS | Kinetic Medical Products | Jan 27, 1989 | SESE |
| K884373 | KORBER ARTERIOTOMY SCISSORS | Micrins, Ltd. | Nov 8, 1988 | SESE |
| K884095 | SCISSORS, WIRE CUTTING | Magnatrade Corp. | Oct 19, 1988 | SESE |
| K873046 | OVONIC COATED SURGICAL SCISSORS | Micrins, Ltd. | Aug 26, 1987 | SESE |
| K871923 | MICRO SCISSOR, 1.7MM | Arthropedics, Inc. | Jun 1, 1987 | SESE |
| K851802 | 69-140 TO 69-160 VARIOUS NAIL CUTTERS | Artiberia | Jun 20, 1985 | SESE |
| K851801 | 69-120 TO 69-132 VARIOUS NAIL SCISSORS | Artiberia | Jun 20, 1985 | SESE |
Top Applicants
- Zinnanti Surgical Instruments, Inc. — 4 clearances
- Solos Endoscopy, Inc. — 2 clearances
- Micrins, Ltd. — 2 clearances
- Kinetic Medical Products — 2 clearances
- Artiberia — 2 clearances
