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FDA 510(k)

Cryocare CS Surgical System

K-Number: K153489 · 2016-02-05

ApplicantHealthtronics
Decision Date2016-02-05
Product CodeGEH
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Cryocare CS Surgical System is the device name listed in this FDA 510(k) record. The listed applicant is Healthtronics. It received FDA 510(k) clearance on 2016-02-05 under 510(k) number K153489. 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 CS Surgical System?

Cryocare CS Surgical System is a medical device that received FDA 510(k) clearance on 2016-02-05. The listed applicant is Healthtronics. The 510(k) number is K153489.

When did Cryocare CS Surgical System receive FDA 510(k) clearance?

Cryocare CS Surgical System received FDA 510(k) clearance on 2016-02-05, under 510(k) number K153489.

Who is the listed applicant for Cryocare CS Surgical System?

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

What is the FDA product code for Cryocare CS Surgical System?

The FDA product code for Cryocare CS Surgical System is GEH.

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.

K261068Maverix 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.K251928CoolCryo - Cryoapplicator for cardiac cryoablation (CC01-01); CoolCryo - Control console for cardiac cryoablation with liquid nitrogen reservoir (CC01-21)Medinice S.A.

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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