510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K935933Substantially Equivalent

Custom Burn Dressing

McNeil Healthcare LLC, Waterford CT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K935933 is the FDA 510(k) clearance record for CUSTOM BURN DRESSING, cleared for Mcneil Healthcare, Inc. on under FDA product code EFQ (Gauze/Sponge, Internal). FDA records list 19 510(k) clearances for Mcneil Healthcare, Inc., from to . As of , FDA records show no recalls naming K935933.

Clearance record

Decision date
Received
(32 days to decision)
Product code
EFQ Gauze/Sponge, Internal
Device class
Unclassified
Review panel
Unknown
Applicant
Mcneil Healthcare, Inc. P.O. Box 964, Waterford CT
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