510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K914235Substantially Equivalent

Asep Surgeons Gown

Baxter Interwoven Offsite, Tampa FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K914235 is the FDA 510(k) clearance record for ASEP SURGEONS GOWN, a class II device, cleared for Baxter Interwoven Offsite on under FDA product code FYA (Gown, Surgical). FDA records list one 510(k) clearance for Baxter Interwoven Offsite. As of , FDA records show no recalls naming K914235.

Clearance record

Decision date
Received
(207 days to decision)
Product code
FYA Gown, Surgical
Regulation
21 CFR 878.4040
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Baxter Interwoven Offsite 2441 Tampa E. Blvd., Tampa FL
510(k) summary
Statement
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