510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K982280Substantially Equivalent

Cryopro Maxi and Cryopro Mini

Cortex Technology ApS, Washington DC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K982280 is the FDA 510(k) clearance record for CRYOPRO MAXI AND CRYOPRO MINI, a class II device, cleared for Cortex Technology Aps on under FDA product code GEH (Unit, Cryosurgical, Accessories). FDA records list 2 510(k) clearances for Cortex Technology Aps, from to . As of , FDA records show no recalls naming K982280.

Clearance record

Decision date
Received
(148 days to decision)
Product code
GEH Unit, Cryosurgical, Accessories
Regulation
21 CFR 878.4350
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Cortex Technology Aps 1050 Connecticut Ave., NW, Washington DC
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