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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Varian Medical Systems, Inc.. It received FDA 510(k) clearance on 2023-03-28 under 510(k) 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. The listed applicant is Varian Medical Systems, Inc.. The 510(k) number is K230271.

When did ISOLIS Cryoprobe receive FDA 510(k) clearance?

ISOLIS Cryoprobe received FDA 510(k) clearance on 2023-03-28, under 510(k) number K230271.

Who is the listed applicant for ISOLIS Cryoprobe?

The FDA 510(k) record lists Varian Medical Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

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.

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