510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K112536Substantially Equivalent

Sonicision Sterilization Tray

Medtronic, Inc., Boulder CO / Abbreviated, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K112536 is the FDA 510(k) clearance record for SONICISION STERILIZATION TRAY, a class II device, cleared for Covidien on under FDA product code KCT (Sterilization Wrap Containers, Trays, Cassettes & Other Accessories). FDA records list 1,525 510(k) clearances for Medtronic, Inc., from to . As of , FDA records show no recalls naming K112536.

Clearance record

Decision date
Received
(231 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
Covidien 5920 Longbow Dr., Boulder CO
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