510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K921243Substantially Equivalent

Convertors Sterilization Wrap

Baxter Healthcare Corporation, Waukegan IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K921243 is the FDA 510(k) clearance record for CONVERTORS STERILIZATION WRAP, a class II device, cleared for Baxter Healthcare Corp on under FDA product code FRG (Wrap, Sterilization). FDA records list 570 510(k) clearances for Baxter Healthcare Corp, from to . As of , FDA records show no recalls naming K921243.

Clearance record

Decision date
Received
(229 days to decision)
Product code
FRG Wrap, Sterilization
Regulation
21 CFR 880.6850
Device class
Class II
Review panel
General Hospital
Applicant
Baxter Healthcare Corp 1500 Waukegan Rd., Waukegan 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