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FDA 510(k)

ENDOCARE CRYOTHERAPY SYSTEM

K-Number: K942299 · 1995-01-19

ApplicantCytocare, Inc.
Decision Date1995-01-19
Product CodeGEH
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ENDOCARE CRYOTHERAPY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Cytocare, Inc.. It received FDA 510(k) clearance on 1995-01-19 under 510(k) number K942299. 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 ENDOCARE CRYOTHERAPY SYSTEM?

ENDOCARE CRYOTHERAPY SYSTEM is a medical device that received FDA 510(k) clearance on 1995-01-19. The listed applicant is Cytocare, Inc.. The 510(k) number is K942299.

When did ENDOCARE CRYOTHERAPY SYSTEM receive FDA 510(k) clearance?

ENDOCARE CRYOTHERAPY SYSTEM received FDA 510(k) clearance on 1995-01-19, under 510(k) number K942299.

Who is the listed applicant for ENDOCARE CRYOTHERAPY SYSTEM?

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 CRYOTHERAPY SYSTEM?

The FDA product code for ENDOCARE CRYOTHERAPY SYSTEM is GEH.

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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.

K954321ENDOCARE MONOPOLAR ELECTRODES (MODIFICATION)K952698ENDOCARE ELECTROSURGICAL HANDPIECEK952587ENDOCARE MONOPOLAR ELECTRODESK945054ENDOCARE PROLASE I ADVANCED LASER DELIVERY SYSTEMK934211CYTOCARE DIODE LASER SYSTEMK921708CYTOCARE LASER CATHETER FOR UROLOGY

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Related Devices (Code: GEH)

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.

K262420Maverix Cryo Biopsy Pro (MCB Pro) (MCBP-1000); Maverix Cryo Cartridge (CC-1000)Serpex MedicalK261068Maverix Cryo Biopsy Probe (MCB1000);Maverix Cryo Cartridge (CC1000)Serpex MedicalK261806ERBECRYO 2 Cryosurgical Unit and AccessoriesErbe Elektromedizin GmbHK253230ERBECRYO 2 Cryosurgical Unit and Accessories: ERBECRYO 2 cryosurgical unit; Erbe Flexible CryoprobeErbe Elektromedizin GmbHK252198Advanced Cryo Skin Tag Remover (Advanced Skin Tag Remover)Medical Brands Laboratories B.V.K260377XSense Cryoablation System with CryoProbesIceCure Medical , Ltd.

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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