GEC — Brush, Scrub, Operating-Room Class I
FDA product code GEC covers "Brush, Scrub, Operating-Room", a Class I medical device regulated under 21 CFR 878.4800. Submissions are reviewed by the General, Plastic Surgery panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- GEC
- Device Class
- Class I
- Regulation Number
- 878.4800
- Submission Type
- Review Panel
- SU
- Medical Specialty
- General, Plastic Surgery
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K971473 | m-pact worldwide management | IVALON INSTRUMENT WIPE, IVALON KNIFE CLEANING BLOCK | July 7, 1997 |
| K960621 | shippert medical technologies | EXPANDACELL INSTRUMENT WIPE | April 1, 1996 |
| K900691 | bio-dyne | BIODYNE INSTRUMENT WIPES | March 8, 1990 |
| K896085 | sparta surgical | SURGI-BRUSH | November 8, 1989 |
| K875033 | medsurg industries | STERILE SCRUBBY SCRUB BRUSH | February 19, 1988 |
| K875129 | absorbent cotton co | STERI-CLENS | February 18, 1988 |
| K872823 | pacific biosystems | DELTA SCRUB | January 7, 1988 |
| K874653 | surgikos | STERILE SURGICAL SCRUB BRUSH | December 30, 1987 |
| K874741 | absorbent cotton co | STERI-CLENS(TM) SURGICAL SCRUB SPONGE | December 10, 1987 |
| K870258 | k. w. griffen | BIOSCRUB SURGICAL SCRUB BRUSH | February 24, 1987 |
| K854232 | american pharmaseal div. ahsc | PHARMASEAL SCRUB CARE-SURGICAL SCRUB BRUSH SPONGES | December 10, 1985 |
| K844411 | american sterilizer | SCRUB MATE DRY STERILE SCRUB BRUSH | December 17, 1984 |
| K843636 | ballard medical products | FOAM CARE ONE STEP PREP | November 16, 1984 |
| K831488 | minnetonka | DAVRON PROF. SCRUB BRUSH-DRY/STERILE | June 8, 1983 |
| K831226 | ballard medical products | MEDICAL PRODUCTS FOAM DOUBLE SCRUB #450 | May 16, 1983 |
| K830393 | h and p industries | PROVIDONE-IODINE SWABSTICKS | April 6, 1983 |
| K830394 | h and p industries | PROVIDONE-IODINE PREP-PADS & TOWELETTES | April 6, 1983 |
| K823173 | buckeye cellulose | ARRIRM SCRUB BRUSH/SPONGE | November 22, 1982 |
| K823061 | seamless hospital products | BRUSH, SCRUB, OPERATING ROOM | November 5, 1982 |
| K822865 | acme united | SURGI-SCRUB V | October 18, 1982 |