510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K070078Substantially Equivalent

Stryker T4 Hytrel Toga

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

K070078 is the FDA 510(k) clearance record for STRYKER T4 HYTREL TOGA, a class II device, cleared for Stryker Instruments, Instruments Div. on under FDA product code FYA (Gown, Surgical). FDA records list 568 510(k) clearances for STRYKER CORP., from to . As of , FDA records show 27 recalls naming K070078.

Clearance record

Decision date
Received
(24 days to decision)
Product code
FYA Gown, Surgical
Regulation
21 CFR 878.4040
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Stryker Instruments, Instruments Div. 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