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FDA 510(k)

CRYOCARE SURGICAL SYSTEM

K-Number: K011074 · 2002-01-25

ApplicantEndocare, Inc.
Decision Date2002-01-25
Product CodeGEH
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CRYOCARE 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 2002-01-25 under 510(k) number K011074. 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 SURGICAL SYSTEM?

CRYOCARE SURGICAL SYSTEM is a medical device that received FDA 510(k) clearance on 2002-01-25. The listed applicant is Endocare, Inc.. The 510(k) number is K011074.

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

CRYOCARE SURGICAL SYSTEM received FDA 510(k) clearance on 2002-01-25, under 510(k) number K011074.

Who is the listed applicant for CRYOCARE 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 CRYOCARE SURGICAL SYSTEM?

The FDA product code for CRYOCARE SURGICAL SYSTEM is GEH.

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Other records listing Endocare, 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.

K101333CRYOCARE CS SURGICAL SYSTEMK062175CRYOCARE CN2 SYSTEMK060279CRYOCARE CS SURGICAL SYSTEMK050347MODIFICATION TO CRYOCARE CS SURGICAL SYSTEMK032333CRYOCARE CS SURGICAL SYSTEMK023757CRYOCARE SURGICAL SYSTEM, MODEL CRYO 20

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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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