510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K012214Substantially Equivalent

Cryopen and Accessories

Cimex Biotech, LLC, Covington LA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K012214 is the FDA 510(k) clearance record for CRYOPEN AND ACCESSORIES, a class II device, cleared for Cimex Biotech, LLC on under FDA product code GEH (Unit, Cryosurgical, Accessories). FDA records list one 510(k) clearance for Cimex Biotech, LLC. As of , FDA records show no recalls naming K012214.

Clearance record

Decision date
Received
(284 days to decision)
Product code
GEH Unit, Cryosurgical, Accessories
Regulation
21 CFR 878.4350
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Cimex Biotech, LLC 72385 Industry Park, Covington LA
510(k) summary
Summary
Third party review
No

Clearances, product code GEH

Trailing 12 months
9 clearances under product code GEH in the twelve months to October 2026, February 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code GEH, trailing twelve months
MonthClearances
November 20250
December 20251
January 20261
February 20262
March 20260
April 20262
May 20260
June 20262
July 20260
August 20260
September 20261
October 20260