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FDA 510(k)

CRYOCARE CN2 SYSTEM

K-Number: K062175 · 2006-08-28

ApplicantEndocare, Inc.
Decision Date2006-08-28
Product CodeGEH
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CRYOCARE CN2 SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Endocare, Inc.. It received FDA 510(k) clearance on 2006-08-28 under 510(k) number K062175. 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 CN2 SYSTEM?

CRYOCARE CN2 SYSTEM is a medical device that received FDA 510(k) clearance on 2006-08-28. The listed applicant is Endocare, Inc.. The 510(k) number is K062175.

When did CRYOCARE CN2 SYSTEM receive FDA 510(k) clearance?

CRYOCARE CN2 SYSTEM received FDA 510(k) clearance on 2006-08-28, under 510(k) number K062175.

Who is the listed applicant for CRYOCARE CN2 SYSTEM?

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

What is the FDA product code for CRYOCARE CN2 SYSTEM?

The FDA product code for CRYOCARE CN2 SYSTEM is GEH.

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Other records listing Endocare, Inc. as applicant

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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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