510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K061308Substantially Equivalent

Trimax, Model 9515N, Breathable Surgical Gown, Models 3247An and 9015N and Optima or Surgical Gown, Model 9506N

Medtronic, Inc., Waukegan IL / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K061308 is the FDA 510(k) clearance record for TRIMAX, MODEL 9515N, BREATHABLE SURGICAL GOWN, MODELS 3247AN AND 9015N AND OPTIMA OR SURGICAL GOWN, MODEL 9506N, a class II device, cleared for Cardinal Health 200, Inc. on under FDA product code FYA (Gown, Surgical). FDA records list 1,525 510(k) clearances for Medtronic, Inc., from to . As of , FDA records show 6 recalls naming K061308.

Clearance record

Decision date
Received
(26 days to decision)
Product code
FYA Gown, Surgical
Regulation
21 CFR 878.4040
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Cardinal Health 200, Inc. 1500 Waukegan Rd., Waukegan IL
510(k) summary
Summary PDF
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