510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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K121904Substantially Equivalent

Gynecology Sterilization Tray

Smith & Nephew, Inc., Andover MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K121904 is the FDA 510(k) clearance record for GYNECOLOGY STERILIZATION TRAY, a class II device, cleared for Smith & Nephew Inc., Endoscopy Division on under FDA product code KCT (Sterilization Wrap Containers, Trays, Cassettes & Other Accessories). FDA records list 572 510(k) clearances for SMITH & NEPHEW INC., from to . As of , FDA records show no recalls naming K121904.

Clearance record

Decision date
Received
(255 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
Smith & Nephew Inc., Endoscopy Division 150 Minuteman Rd., Andover MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code KCT

Trailing 12 months
8 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 20261
November 20260