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FDA 510(k)

CRYOSUCCESS, MODEL C-SUC-01, C-SUC-02, C-DTS-02, C-DTS-03, C-GTS-13. C-CA-23

K-Number: K091721 · 2009-10-02

ApplicantNew Medical Technologies GmbH
Decision Date2009-10-02
Product CodeGEH
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CRYOSUCCESS, MODEL C-SUC-01, C-SUC-02, C-DTS-02, C-DTS-03, C-GTS-13. C-CA-23 is the device name listed in this FDA 510(k) record. The listed applicant is New Medical Technologies GmbH. It received FDA 510(k) clearance on 2009-10-02 under 510(k) number K091721. 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 CRYOSUCCESS, MODEL C-SUC-01, C-SUC-02, C-DTS-02, C-DTS-03, C-GTS-13. C-CA-23?

CRYOSUCCESS, MODEL C-SUC-01, C-SUC-02, C-DTS-02, C-DTS-03, C-GTS-13. C-CA-23 is a medical device that received FDA 510(k) clearance on 2009-10-02. The listed applicant is New Medical Technologies GmbH. The 510(k) number is K091721.

When did CRYOSUCCESS, MODEL C-SUC-01, C-SUC-02, C-DTS-02, C-DTS-03, C-GTS-13. C-CA-23 receive FDA 510(k) clearance?

CRYOSUCCESS, MODEL C-SUC-01, C-SUC-02, C-DTS-02, C-DTS-03, C-GTS-13. C-CA-23 received FDA 510(k) clearance on 2009-10-02, under 510(k) number K091721.

Who is the listed applicant for CRYOSUCCESS, MODEL C-SUC-01, C-SUC-02, C-DTS-02, C-DTS-03, C-GTS-13. C-CA-23?

The FDA 510(k) record lists New Medical Technologies GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CRYOSUCCESS, MODEL C-SUC-01, C-SUC-02, C-DTS-02, C-DTS-03, C-GTS-13. C-CA-23?

The FDA product code for CRYOSUCCESS, MODEL C-SUC-01, C-SUC-02, C-DTS-02, C-DTS-03, C-GTS-13. C-CA-23 is GEH.

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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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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