510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K954090Substantially Equivalent

Auto Suture* Sterilization Tray**

United States Surgical, A Division of Tyco Healthc, Norwalk CT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K954090 is the FDA 510(k) clearance record for AUTO SUTURE* STERILIZATION TRAY**, a class II device, cleared for United States Surgical, A Division of Tyco Healthc on under FDA product code KCT (Sterilization Wrap Containers, Trays, Cassettes & Other Accessories). FDA records list 218 510(k) clearances for United States Surgical, A Division of Tyco Healthc, from to . As of , FDA records show no recalls naming K954090.

Clearance record

Decision date
Received
(83 days to decision)
Product code
KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Regulation
21 CFR 880.6850
Device class
Class II
Review panel
General Hospital
Applicant
United States Surgical, A Division of Tyco Healthc 150 Glover Ave., Norwalk CT
510(k) summary
Summary
Third party review
No

Clearances, product code KCT

Trailing 12 months
9 clearances under product code KCT in the twelve months to November 2026, June 2026 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code KCT, trailing twelve months
MonthClearances
December 20250
January 20260
February 20262
March 20260
April 20260
May 20260
June 20263
July 20260
August 20260
September 20262
October 20262
November 20260