510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K875129Substantially Equivalent

Steri-Clens

Absorbent Cotton Co., Inc., Hammonton NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K875129 is the FDA 510(k) clearance record for STERI-CLENS, a class I device, cleared for Absorbent Cotton Co., Inc. on under FDA product code GEC (Brush, Scrub, Operating-Room). FDA records list 10 510(k) clearances for Absorbent Cotton Co., Inc., from to . As of , FDA records show no recalls naming K875129.

Clearance record

Decision date
Received
(65 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
Absorbent Cotton Co., Inc. P.O. Box 268, Hammonton NJ
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