510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K803188Substantially Equivalent

Gauze Sponges

Abco Dealers, Inc., Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K803188 is the FDA 510(k) clearance record for GAUZE SPONGES, a class I device, cleared for Abco Dealers, Inc. on under FDA product code GDY (Gauze/Sponge, Internal, X-Ray Detectable). FDA records list 127 510(k) clearances for Abco Dealers, Inc., from to . As of , FDA records show no recalls naming K803188.

Clearance record

Decision date
Received
(30 days to decision)
Product code
GDY Gauze/Sponge, Internal, X-Ray Detectable
Regulation
21 CFR 878.4450
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Abco Dealers, Inc. 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code GDY

Trailing 12 months

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

FDA records show no clearances under product code GDY in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code GDY, 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