510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K903358Substantially Equivalent

Advance Laparotomy Sponge, Lap Sponge

Advance Medical Designs Inc, Marietta GA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K903358 is the FDA 510(k) clearance record for ADVANCE LAPAROTOMY SPONGE, LAP SPONGE, a class I device, cleared for Advance Medical Designs, Inc. on under FDA product code GDY (Gauze/Sponge, Internal, X-Ray Detectable). FDA records list 32 510(k) clearances for Advance Medical Designs, Inc., from to . As of , FDA records show no recalls naming K903358.

Clearance record

Decision date
Received
(126 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
Advance Medical Designs, Inc. 808 Pickens Industrial Dr., Marietta GA
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