510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K935257Substantially Equivalent

Medicom Non-Woven Sponges

A.R. Medicom, Inc., Quebec, H4m 2n5 Canada, CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K935257 is the FDA 510(k) clearance record for MEDICOM NON-WOVEN SPONGES, cleared for A.R. Medicom, Inc. on under FDA product code EFQ (Gauze/Sponge, Internal). FDA records list 3 510(k) clearances for A.R. Medicom, Inc., from to . As of , FDA records show no recalls naming K935257.

Clearance record

Decision date
Received
(164 days to decision)
Product code
EFQ Gauze/Sponge, Internal
Device class
Unclassified
Review panel
Unknown
Applicant
A.R. Medicom, Inc. 910 Rue Begin, Quebec, H4m 2n5 Canada, CA
510(k) summary
Statement
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