510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K852857Substantially Equivalent

4 X 4' Gauze Pad

Cornelia Damsky, Inc., Stamford CT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K852857 is the FDA 510(k) clearance record for 4 X 4' GAUZE PAD, cleared for Cornelia Damsky, Inc. on under FDA product code EFQ (Gauze/Sponge, Internal). FDA records list 4 510(k) clearances for Cornelia Damsky, Inc., from to . As of , FDA records show no recalls naming K852857.

Clearance record

Decision date
Received
(21 days to decision)
Product code
EFQ Gauze/Sponge, Internal
Device class
Unclassified
Review panel
Unknown
Applicant
Cornelia Damsky, Inc. 56 Westcott Rd., Stamford CT
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