510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K031482Substantially Equivalent

Cryostar System, Comprising: a) Cryostar Console, B) Cryostar 1Mm Cryoprobe, C) Cryostar 2Mm Cryoprobe, D) Convenience

Cryomedical Instruemts, Ltd., Mansfield Woodhouse, Notts, GB / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K031482 is the FDA 510(k) clearance record for CRYOSTAR SYSTEM, COMPRISING: A) CRYOSTAR CONSOLE, B) CRYOSTAR 1MM CRYOPROBE, C) CRYOSTAR 2MM CRYOPROBE, D) CONVENIENCE, a class II device, cleared for Cryomedical Instruemts , Ltd. on under FDA product code GXH (Device, Surgical, Cryogenic). FDA records list one 510(k) clearance for Cryomedical Instruemts , Ltd. As of , FDA records show no recalls naming K031482.

Clearance record

Decision date
Received
(59 days to decision)
Product code
GXH Device, Surgical, Cryogenic
Regulation
21 CFR 882.4250
Device class
Class II
Review panel
Neurology
Applicant
Cryomedical Instruemts , Ltd. Cryomed House, Grove Way, Mansfield Woodhouse, Notts, GB
510(k) summary
Summary PDF
Third party review
No

Clearances, product code GXH

Trailing 12 months

FDA records hold no clearances under product code GXH in the trailing twelve months.

FDA records show no clearances under product code GXH in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code GXH, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260