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FDA 510(k)

ENDOCARE MONOPOLAR ELECTRODE

K-Number: K965118 · 1997-02-25

ApplicantEndocare, Inc.
Decision Date1997-02-25
Product CodeFAS
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ENDOCARE MONOPOLAR ELECTRODE is the device name listed in this FDA 510(k) record. The listed applicant is Endocare, Inc.. It received FDA 510(k) clearance on 1997-02-25 under 510(k) number K965118. The device is classified under product code FAS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENDOCARE MONOPOLAR ELECTRODE?

ENDOCARE MONOPOLAR ELECTRODE is a medical device that received FDA 510(k) clearance on 1997-02-25. The listed applicant is Endocare, Inc.. The 510(k) number is K965118.

When did ENDOCARE MONOPOLAR ELECTRODE receive FDA 510(k) clearance?

ENDOCARE MONOPOLAR ELECTRODE received FDA 510(k) clearance on 1997-02-25, under 510(k) number K965118.

Who is the listed applicant for ENDOCARE MONOPOLAR ELECTRODE?

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 ENDOCARE MONOPOLAR ELECTRODE?

The FDA product code for ENDOCARE MONOPOLAR ELECTRODE is FAS.

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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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