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FDA 510(k)

MODIFICATION TO CRYOCARE CS SURGICAL SYSTEM

K-Number: K050347 · 2005-02-25

ApplicantEndocare, Inc.
Decision Date2005-02-25
Product CodeGEH
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO CRYOCARE CS SURGICAL 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 2005-02-25 under 510(k) number K050347. 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 MODIFICATION TO CRYOCARE CS SURGICAL SYSTEM?

MODIFICATION TO CRYOCARE CS SURGICAL SYSTEM is a medical device that received FDA 510(k) clearance on 2005-02-25. The listed applicant is Endocare, Inc.. The 510(k) number is K050347.

When did MODIFICATION TO CRYOCARE CS SURGICAL SYSTEM receive FDA 510(k) clearance?

MODIFICATION TO CRYOCARE CS SURGICAL SYSTEM received FDA 510(k) clearance on 2005-02-25, under 510(k) number K050347.

Who is the listed applicant for MODIFICATION TO CRYOCARE CS SURGICAL 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 MODIFICATION TO CRYOCARE CS SURGICAL SYSTEM?

The FDA product code for MODIFICATION TO CRYOCARE CS SURGICAL SYSTEM is GEH.

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Other records listing Endocare, Inc. as applicant

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K101333CRYOCARE CS SURGICAL SYSTEMK062175CRYOCARE CN2 SYSTEMK060279CRYOCARE CS SURGICAL SYSTEMK032333CRYOCARE CS SURGICAL SYSTEMK023757CRYOCARE SURGICAL SYSTEM, MODEL CRYO 20K021010MODIFIED CARDIAC CRYOSURGICAL SYSTEM, MODELS 6TCS1 & 6TCSE

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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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