510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K012931Substantially Equivalent

Genesis Sterrad Compatible Reusable Sterilization Container System

Medtronic, Inc., Mcgraw Park IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K012931 is the FDA 510(k) clearance record for GENESIS STERRAD COMPATIBLE REUSABLE STERILIZATION CONTAINER SYSTEM, a class II device, cleared for Allegiance Healthcare Corp. on under FDA product code FRG (Wrap, Sterilization). FDA records list 1,525 510(k) clearances for Medtronic, Inc., from to . As of , FDA records show no recalls naming K012931.

Clearance record

Decision date
Received
(354 days to decision)
Product code
FRG Wrap, Sterilization
Regulation
21 CFR 880.6850
Device class
Class II
Review panel
General Hospital
Applicant
Allegiance Healthcare Corp. 1500 Waukegan Rd.- K, Mcgraw Park IL
510(k) summary
Summary
Third party review
No

Clearances, product code FRG

Trailing 12 months
5 clearances under product code FRG in the twelve months to November 2026, May 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code FRG, trailing twelve months
MonthClearances
December 20251
January 20261
February 20260
March 20260
April 20260
May 20262
June 20260
July 20261
August 20260
September 20260
October 20260
November 20260