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FDA 510(k)

TargetCool

K-Number: K220674 · 2022-03-31

ApplicantRecensmedical, Inc.
Decision Date2022-03-31
Product CodeGEH
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

TargetCool is the device name listed in this FDA 510(k) record. The listed applicant is Recensmedical, Inc.. It received FDA 510(k) clearance on 2022-03-31 under 510(k) number K220674. 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 TargetCool?

TargetCool is a medical device that received FDA 510(k) clearance on 2022-03-31. The listed applicant is Recensmedical, Inc.. The 510(k) number is K220674.

When did TargetCool receive FDA 510(k) clearance?

TargetCool received FDA 510(k) clearance on 2022-03-31, under 510(k) number K220674.

Who is the listed applicant for TargetCool?

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

What is the FDA product code for TargetCool?

The FDA product code for TargetCool is GEH.

Other records listing Recensmedical, 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.

K253114TargetCool™ (RM-DT02W)K253348TargetCool-eK230599TargetCool™K221234TargetCoolK203481CryoVIVE

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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