FDA 510(k)

CRYOCARE TOUCH System and Accessories, Endocare 1.7mm Round Ice PerCryo Cryoprobe, Short, Round Ice

K-Number: K201588 · 2020-08-11

Decision Date2020-08-11

Product CodeGEH

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

CRYOCARE TOUCH System and Accessories, Endocare 1.7mm Round Ice PerCryo Cryoprobe, Short, Round Ice is a medical device manufactured by Varian Medical Systems, Inc.. It received FDA 510(k) clearance on 2020-08-11 under approval number K201588. 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 CRYOCARE TOUCH System and Accessories, Endocare 1.7mm Round Ice PerCryo Cryoprobe, Short, Round Ice?

CRYOCARE TOUCH System and Accessories, Endocare 1.7mm Round Ice PerCryo Cryoprobe, Short, Round Ice is a medical device that received FDA 510(k) clearance on 2020-08-11. It is manufactured by Varian Medical Systems, Inc.. The 510(k) number is K201588.

When was CRYOCARE TOUCH System and Accessories, Endocare 1.7mm Round Ice PerCryo Cryoprobe, Short, Round Ice approved by the FDA?

CRYOCARE TOUCH System and Accessories, Endocare 1.7mm Round Ice PerCryo Cryoprobe, Short, Round Ice received FDA 510(k) clearance on 2020-08-11, under approval number K201588.

What company makes CRYOCARE TOUCH System and Accessories, Endocare 1.7mm Round Ice PerCryo Cryoprobe, Short, Round Ice?

CRYOCARE TOUCH System and Accessories, Endocare 1.7mm Round Ice PerCryo Cryoprobe, Short, Round Ice is manufactured by Varian Medical Systems, Inc..

What is the FDA product code for CRYOCARE TOUCH System and Accessories, Endocare 1.7mm Round Ice PerCryo Cryoprobe, Short, Round Ice?

The FDA product code for CRYOCARE TOUCH System and Accessories, Endocare 1.7mm Round Ice PerCryo Cryoprobe, Short, Round Ice is GEH.

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Related PubMed Literature

PMID: 39977258 Priorities for medical device regulatory approval: a report from the European Society of Cardiology Cardiovascular Round Table. European heart journal (2025)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.