510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K963724Substantially Equivalent for Some Indications

Gauze Sponge, Non X-Ray Detectable

Grand Medical Products, Schaumburg IL / Traditional, Substantially Equivalent for Some Indications
FDA source (opens on fda.gov)

K963724 is the FDA 510(k) clearance record for GAUZE SPONGE, NON X-RAY DETECTABLE, cleared for Grand Medical Products on under FDA product code EFQ (Gauze/Sponge, Internal). FDA records list 8 510(k) clearances for Grand Medical Products, from to . As of , FDA records show no recalls naming K963724.

Clearance record

Decision date
Received
(74 days to decision)
Product code
EFQ Gauze/Sponge, Internal
Device class
Unclassified
Review panel
Unknown
Applicant
Grand Medical Products 1300 Remington Rd., Suite K, Schaumburg IL
Third party review
No

Clearances, product code EFQ

Trailing 12 months

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

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