510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K760365Substantially Equivalent

Blanket, Burn

Winn Hirsch & Assoc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K760365 is the FDA 510(k) clearance record for BLANKET, BURN, a class I device, cleared for Winn Hirsch & Assoc. on under FDA product code FPY (Sheet, Burn). FDA records list 11 510(k) clearances for Winn Hirsch & Assoc., from to . As of , FDA records show no recalls naming K760365.

Clearance record

Decision date
Received
(8 days to decision)
Product code
FPY Sheet, Burn
Regulation
21 CFR 880.5180
Device class
Class I
Review panel
General Hospital
Applicant
Winn Hirsch & Assoc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code FPY

Trailing 12 months

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

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