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FDA 510(k)

ENDOCARE MONOPOLAR ELECTRODES (MODIFICATION)

K-Number: K954321 · 1995-10-13

ApplicantCytocare, Inc.
Decision Date1995-10-13
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ENDOCARE MONOPOLAR ELECTRODES (MODIFICATION) is the device name listed in this FDA 510(k) record. The listed applicant is Cytocare, Inc.. It received FDA 510(k) clearance on 1995-10-13 under 510(k) number K954321. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENDOCARE MONOPOLAR ELECTRODES (MODIFICATION)?

ENDOCARE MONOPOLAR ELECTRODES (MODIFICATION) is a medical device that received FDA 510(k) clearance on 1995-10-13. The listed applicant is Cytocare, Inc.. The 510(k) number is K954321.

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

ENDOCARE MONOPOLAR ELECTRODES (MODIFICATION) received FDA 510(k) clearance on 1995-10-13, under 510(k) number K954321.

Who is the listed applicant for ENDOCARE MONOPOLAR ELECTRODES (MODIFICATION)?

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

What is the FDA product code for ENDOCARE MONOPOLAR ELECTRODES (MODIFICATION)?

The FDA product code for ENDOCARE MONOPOLAR ELECTRODES (MODIFICATION) is GEI.

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Other records listing Cytocare, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K952698ENDOCARE ELECTROSURGICAL HANDPIECEK952587ENDOCARE MONOPOLAR ELECTRODESK942299ENDOCARE CRYOTHERAPY SYSTEMK945054ENDOCARE PROLASE I ADVANCED LASER DELIVERY SYSTEMK934211CYTOCARE DIODE LASER SYSTEMK921708CYTOCARE LASER CATHETER FOR UROLOGY

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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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