FSM · Tray, Surgical, Instrument
General, Plastic Surgery · 21 CFR 878.4800 · Class 1
Overview
| Product Code | FSM |
|---|---|
| Device Name | Tray, Surgical, Instrument |
| 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 76)
Showing 20 most recent of 76 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K971217 | INSTRUMENT TRAY LINER | General Hospital Supply Corp. | May 6, 1997 | SESE |
| K962328 | SINGLE USE INSTRUMENT TRAY | Medcare Medical Group, Inc. | Aug 9, 1996 | SESE |
| K944025 | SURGICAL INSTRUMENT TRAY | Riley Medical, Inc. | Nov 22, 1994 | SESE |
| K912106 | ARTHROSCOPY TRAY | Medical Device Inspection Co., Inc. | Aug 29, 1991 | SESE |
| K912053 | OPEN HEART TRAY | Medical Device Inspection Co., Inc. | Aug 26, 1991 | SESE |
| K912052 | HEART CATH TRAY | Medical Device Inspection Co., Inc. | Aug 20, 1991 | SESE |
| K912104 | MAJOR BASIN TRAY | Medical Device Inspection Co., Inc. | Aug 9, 1991 | SESE |
| K910570 | SPLINTER TWEEZERS | Solan Scissors Sales | May 31, 1991 | SESE |
| K911601 | REDDICK TROCAR AND CANNULA | Ideal Medical, Inc. | May 21, 1991 | SESE |
| K910328 | KEY COMFORT GRIPS | Key Surgical, Inc. | Mar 6, 1991 | SESE |
| K905682 | RICHARD-ALLAN CLAMP COVERS | Richard-Allan Medical | Feb 19, 1991 | SESE |
| K900376 | HAND SURGERY AND IRRIGATION TRAY (MODEL 3625) | Pmt Corp. | Apr 10, 1990 | SESE |
| K894610 | CUSTOM TRAYS, KITS | L H M Ent., Inc. | Mar 15, 1990 | SESD |
| K900479 | STERILE LACERATION TRAY CAT. #749 | Busse Hospital Disposables, Inc. | Feb 13, 1990 | SESE |
| K895527 | THE NEEDLE COUNT AND SHARPS DISPOSAL SYSTEM | Quantitative Technologies, Inc. | Oct 6, 1989 | SESE |
| K883193 | CASF STERILIZATION TRAY | Terray Manufacturing, Inc. | Aug 10, 1988 | SESE |
| K883125 | CASF STERILIZATION TRAY | Terray Manufacturing, Inc. | Aug 10, 1988 | SESE |
| K882617 | BREVET CASSETTE STERILIZATION MODULE | Brevet, Inc. | Jul 28, 1988 | SESE |
| K871924 | STERILIZATION TRAY, TMJ INSTRUMENT SET | Arthropedics, Inc. | Jun 1, 1987 | SESE |
| K871478 | SURGICAL PACKS, SURGICAL KITS AND SURGICAL TRAYS | Procedure Pak, Inc. | May 7, 1987 | SESE |
Top Applicants
- Medcare Products — 5 clearances
- Ascep, Inc. — 4 clearances
- Medical Device Inspection Co., Inc. — 4 clearances
- American Pharmaseal Div. Ahsc — 3 clearances
- Associated Medical Products Co. — 3 clearances
