510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K141095Substantially Equivalent

Stryker Steri-Shield Flyte Hybrid Togas

Stryker Corp., Kalamazoo MI / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K141095 is the FDA 510(k) clearance record for STRYKER STERI-SHIELD FLYTE HYBRID TOGAS, a class II device, cleared for Stryker Corporation on under FDA product code FYA (Gown, Surgical). FDA records list 568 510(k) clearances for Stryker Corporation, from to . As of , FDA records show no recalls naming K141095.

Clearance record

Decision date
Received
(120 days to decision)
Product code
FYA Gown, Surgical
Regulation
21 CFR 878.4040
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Stryker Corporation 4100 E. Milham Ave., Kalamazoo MI
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