510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K910515Substantially Equivalent

Freedom Mark III Surgical Helmet System

Stackhouse Assoc., Riverside CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K910515 is the FDA 510(k) clearance record for FREEDOM MARK III SURGICAL HELMET SYSTEM, a class II device, cleared for Stackhouse Assoc. on under FDA product code FYA (Gown, Surgical). FDA records list 5 510(k) clearances for Stackhouse Assoc., from to . As of , FDA records show 15 recalls naming K910515.

Clearance record

Decision date
Received
(90 days to decision)
Product code
FYA Gown, Surgical
Regulation
21 CFR 878.4040
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Stackhouse Assoc. 2059 Atlanta Ave., Riverside CA
Third party review
No

Clearances, product code FYA

Trailing 12 months
10 clearances under product code FYA in the twelve months to October 2026, February 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code FYA, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20262
March 20260
April 20262
May 20261
June 20261
July 20261
August 20262
September 20260
October 20260