Atlas FDA

GEC

37 FDA 510(k) clearances · Product code

29 daysmedian time to decision
65 days90th percentile
37clearances measured

FDA profile

Official device name
Brush, Scrub, Operating-Room
Device class
Class I (low risk)
Regulation
21 CFR 878.4800
Medical specialty
General, Plastic Surgery
Adverse events (MAUDE)
2001: 3 · 2002: 2 · 2003: 1 · 2004: 4 · 2009: 6 · 2021: 16
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
IVALON INSTRUMENT WIPE, IVALON KNIFE CLEANING BLOCK (K971473)M-Pact Worldwide Management Corp.1997-07-07
EXPANDACELL INSTRUMENT WIPE (K960621)Shippert Medical Technologies Corp.1996-04-01
BIODYNE INSTRUMENT WIPES (K900691)Bio-Dyne, Inc.1990-03-08
SURGI-BRUSH (K896085)Sparta Surgical Corp.1989-11-08
STERILE SCRUBBY SCRUB BRUSH (K875033)Medsurg Industries, Inc.1988-02-19
STERI-CLENS (K875129)Absorbent Cotton Co., Inc.1988-02-18
DELTA SCRUB (K872823)Pacific Biosystems, Inc.1988-01-07
STERILE SURGICAL SCRUB BRUSH (K874653)Surgikos, Inc.1987-12-30
STERI-CLENS(TM) SURGICAL SCRUB SPONGE (K874741)Absorbent Cotton Co., Inc.1987-12-10
BIOSCRUB SURGICAL SCRUB BRUSH (K870258)K. W. Griffen Co.1987-02-24
PHARMASEAL SCRUB CARE-SURGICAL SCRUB BRUSH SPONGES (K854232)American Pharmaseal Div. Ahsc1985-12-10
SCRUB MATE DRY STERILE SCRUB BRUSH (K844411)American Sterilizer Co.1984-12-17
FOAM CARE ONE STEP PREP (K843636)Ballard Medical Products1984-11-16
DAVRON PROF. SCRUB BRUSH-DRY/STERILE (K831488)Minnetonka, Inc.1983-06-08
MEDICAL PRODUCTS FOAM DOUBLE SCRUB #450 (K831226)Ballard Medical Products1983-05-16
PROVIDONE-IODINE PREP-PADS & TOWELETTES (K830394)H & P Industries, Inc.1983-04-06
PROVIDONE-IODINE SWABSTICKS (K830393)H & P Industries, Inc.1983-04-06
ARRIRM SCRUB BRUSH/SPONGE (K823173)The Buckeye Cellulose Corp.1982-11-22
BRUSH, SCRUB, OPERATING ROOM (K823061)Seamless Hospital Products Co.1982-11-05
SURGI-SCRUB V (K822865)Acme United Corp.1982-10-18
DISPOSABLE SURGICAL SCRUB BRUSHES (K821497)Medical Systems Research1982-07-14
CURITY SURGICAL SCRUB BRUSH SPONGE (K820086)The Kendal Co.1982-01-28
DISPOSABLE SCRUB BRUSH (K810655)Dexide, Inc.1981-05-05
PDI SURGICAL SCRUB SPONGE-BRUSH-T15070 (K810337)Nice-Pak Products, Inc.1981-02-26
HEAVY DRAINAGE PACK (K803116)American Medical Disposable, Inc.1981-01-28
ANAGO ELECTRO SURGICAL TIP CLEANER (K800058)Anago, Inc.1980-01-28
DEXIDE DIS. SUR. SCRUB SPONGE W/PARACHLO (K792272)Dexide, Inc.1979-12-27
DEXIDE DIS. PREP SPONGE W/IDEX PATIENT P (K792273)Dexide, Inc.1979-12-10
SURGI-PREP PAINT STICK #1 WET PACK (K792242)Gard Research Corp.1979-12-10
DEXIDE DISPOSABLE SURGICAL SCRUB SPONGE (K792271)Dexide, Inc.1979-12-10
DEXIDE DISPOSABLE SURGICAL SCRUB BRUSH (K791949)Dexide, Inc.1979-10-17
DEXIDE DISPOSABLE SURGICAL SCRUB SPONGE (K791951)Dexide, Inc.1979-10-17
DEXIDE DISPOSABLE SURGICAL SCRUB BRUSH (K791952)Dexide, Inc.1979-10-17
DEXIDE DISPOSABLE SURGICAL SCRUB SPONGE (K791950)Dexide, Inc.1979-10-17
MEROCEL INSTRUMENT WIPE (K791736)Xomed, Inc.1979-09-19
SURGERY BRUSH (K782173)Dexide, Inc.1979-01-10
BRUSH/SPONGE, DISPOSABLE (K782172)Dexide, Inc.1979-01-10

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Every clearance here is in the API, with alerts when new ones post.