510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K844675Substantially Equivalent

Applied Gauze Sponge 3X3x12

Applied Medical, Fort Worth TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K844675 is the FDA 510(k) clearance record for APPLIED GAUZE SPONGE 3X3X12, cleared for Applied Medical on under FDA product code EFQ (Gauze/Sponge, Internal). FDA records list 14 510(k) clearances for Applied Medical, from to . As of , FDA records show no recalls naming K844675.

Clearance record

Decision date
Received
(122 days to decision)
Product code
EFQ Gauze/Sponge, Internal
Device class
Unclassified
Review panel
Unknown
Applicant
Applied Medical 7700 Trinity Blvd., Fort Worth TX
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