510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K854232Substantially Equivalent for Some Indications

Pharmaseal Scrub Care-Surgical Scrub Brush Sponges

American Pharmaseal Div. Ahsc, Valencia CA / Traditional, Substantially Equivalent for Some Indications
FDA source (opens on fda.gov)

K854232 is the FDA 510(k) clearance record for PHARMASEAL SCRUB CARE-SURGICAL SCRUB BRUSH SPONGES, a class I device, cleared for American Pharmaseal Div. Ahsc on under FDA product code GEC (Brush, Scrub, Operating-Room). FDA records list 64 510(k) clearances for American Pharmaseal Div. Ahsc, from to . As of , FDA records show no recalls naming K854232.

Clearance record

Decision date
Received
(50 days to decision)
Product code
GEC Brush, Scrub, Operating-Room
Regulation
21 CFR 878.4800
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
American Pharmaseal Div. Ahsc 27200 N. Tourney Rd., Valencia CA
Third party review
No

Clearances, product code GEC

Trailing 12 months

FDA records hold no clearances under product code GEC in the trailing twelve months.

FDA records show no clearances under product code GEC in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code GEC, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260