ISOLIS Cryoprobe
K-Number: K230271 · 2023-03-28
ApplicantVarian Medical Systems, Inc.
Decision Date2023-03-28
Product CodeGEH
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
ISOLIS Cryoprobe is a medical device manufactured by Varian Medical Systems, Inc.. It received FDA 510(k) clearance on 2023-03-28 under approval number K230271. The device is classified under product code GEH. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the ISOLIS Cryoprobe?
ISOLIS Cryoprobe is a medical device that received FDA 510(k) clearance on 2023-03-28. It is manufactured by Varian Medical Systems, Inc.. The 510(k) number is K230271.
When was ISOLIS Cryoprobe approved by the FDA?
ISOLIS Cryoprobe received FDA 510(k) clearance on 2023-03-28, under approval number K230271.
What company makes ISOLIS Cryoprobe?
ISOLIS Cryoprobe is manufactured by Varian Medical Systems, Inc..
What is the FDA product code for ISOLIS Cryoprobe?
The FDA product code for ISOLIS Cryoprobe is GEH.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.