CRYOSTAR SYSTEM, COMPRISING: A) CRYOSTAR CONSOLE, B) CRYOSTAR 1MM CRYOPROBE, C) CRYOSTAR 2MM CRYOPROBE, D) CONVENIENCE— 510(k) K031482

Name: FDA 510(k) clearance K031482
Creator: U.S. Food and Drug Administration
Published: 2003-07-10

Substantially Equivalent

Cryomedical Instruemts , Ltd.

FDA 510(k) clearance K031482 for CRYOSTAR SYSTEM, COMPRISING: A) CRYOSTAR CONSOLE, B) CRYOSTAR 1MM CRYOPROBE, C) CRYOSTAR 2MM CRYOPROBE, D) CONVENIENCE, Substantially Equivalent on 2003-07-10. Applicant: Cryomedical Instruemts , Ltd.. Device class: 2.

Clearance details

Applicant: Cryomedical Instruemts , Ltd.
Product code: Code GXH
Device class: Class 2
Regulation: 21 CFR 882.4250
Advisory panel: Neurology
Date received: 2003-05-12
Decision date: 2003-07-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mansfield Woodhouse, Notts, GB

Download summary PDF View on FDA.gov ↗

Recent devices under product code GXH

view all

K250371 — cryoICE cryoXT cryoablation probe (cryoXT)2025-04-10
K243677 — iovera° System2024-12-26
K243157 — AtriCure cryoICE BOX (ACM)2024-10-29
K233170 — cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP) +3 more2023-10-26
K220656 — iovera System2022-05-20

Data sourced from openFDA. This site is unofficial and independent of the FDA.