GEC · Brush, Scrub, Operating-Room
General, Plastic Surgery · 21 CFR 878.4800 · Class 1
Overview
| Product Code | GEC |
|---|---|
| Device Name | Brush, Scrub, Operating-Room |
| 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 37)
Showing 20 most recent of 37 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K971473 | IVALON INSTRUMENT WIPE, IVALON KNIFE CLEANING BLOCK | M-Pact Worldwide Management Corp. | Jul 7, 1997 | SESE |
| K960621 | EXPANDACELL INSTRUMENT WIPE | Shippert Medical Technologies Corp. | Apr 1, 1996 | SESE |
| K900691 | BIODYNE INSTRUMENT WIPES | Bio-Dyne, Inc. | Mar 8, 1990 | SESE |
| K896085 | SURGI-BRUSH | Sparta Surgical Corp. | Nov 8, 1989 | SESE |
| K875033 | STERILE SCRUBBY SCRUB BRUSH | Medsurg Industries, Inc. | Feb 19, 1988 | SESD |
| K875129 | STERI-CLENS | Absorbent Cotton Co., Inc. | Feb 18, 1988 | SESE |
| K872823 | DELTA SCRUB | Pacific Biosystems, Inc. | Jan 7, 1988 | SESE |
| K874653 | STERILE SURGICAL SCRUB BRUSH | Surgikos, Inc. | Dec 30, 1987 | SESE |
| K874741 | STERI-CLENS(TM) SURGICAL SCRUB SPONGE | Absorbent Cotton Co., Inc. | Dec 10, 1987 | SESE |
| K870258 | BIOSCRUB SURGICAL SCRUB BRUSH | K. W. Griffen Co. | Feb 24, 1987 | SESE |
| K854232 | PHARMASEAL SCRUB CARE-SURGICAL SCRUB BRUSH SPONGES | American Pharmaseal Div. Ahsc | Dec 10, 1985 | SN |
| K844411 | SCRUB MATE DRY STERILE SCRUB BRUSH | American Sterilizer Co. | Dec 17, 1984 | SESE |
| K843636 | FOAM CARE ONE STEP PREP | Ballard Medical Products | Nov 16, 1984 | SESE |
| K831488 | DAVRON PROF. SCRUB BRUSH-DRY/STERILE | Minnetonka, Inc. | Jun 8, 1983 | SESE |
| K831226 | MEDICAL PRODUCTS FOAM DOUBLE SCRUB #450 | Ballard Medical Products | May 16, 1983 | SESE |
| K830394 | PROVIDONE-IODINE PREP-PADS & TOWELETTES | H & P Industries, Inc. | Apr 6, 1983 | SESE |
| K830393 | PROVIDONE-IODINE SWABSTICKS | H & P Industries, Inc. | Apr 6, 1983 | SESE |
| K823173 | ARRIRM SCRUB BRUSH/SPONGE | The Buckeye Cellulose Corp. | Nov 22, 1982 | SESE |
| K823061 | BRUSH, SCRUB, OPERATING ROOM | Seamless Hospital Products Co. | Nov 5, 1982 | SESE |
| K822865 | SURGI-SCRUB V | Acme United Corp. | Oct 18, 1982 | SESE |
Top Applicants
- Dexide, Inc. — 10 clearances
- H & P Industries, Inc. — 2 clearances
- Ballard Medical Products — 2 clearances
- Absorbent Cotton Co., Inc. — 2 clearances
- Xomed, Inc. — 1 clearance
