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FDA 510(k)

MYOSCIENCE CRYO-TOUCH

K-Number: K083493 · 2009-03-20

ApplicantMyoscience, Inc.
Decision Date2009-03-20
Product CodeGEH
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MYOSCIENCE CRYO-TOUCH is the device name listed in this FDA 510(k) record. The listed applicant is Myoscience, Inc.. It received FDA 510(k) clearance on 2009-03-20 under 510(k) number K083493. 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 MYOSCIENCE CRYO-TOUCH?

MYOSCIENCE CRYO-TOUCH is a medical device that received FDA 510(k) clearance on 2009-03-20. The listed applicant is Myoscience, Inc.. The 510(k) number is K083493.

When did MYOSCIENCE CRYO-TOUCH receive FDA 510(k) clearance?

MYOSCIENCE CRYO-TOUCH received FDA 510(k) clearance on 2009-03-20, under 510(k) number K083493.

Who is the listed applicant for MYOSCIENCE CRYO-TOUCH?

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

What is the FDA product code for MYOSCIENCE CRYO-TOUCH?

The FDA product code for MYOSCIENCE CRYO-TOUCH is GEH.

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Other records listing Myoscience, Inc. as applicant

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K173763iovera systemK161835iovera systemK123516CRYO-TOUCH IVK120415CRYO-TOUCH IIIK102021CRYO-TOUCH IIK100447MYOSCIENCE CRYO-TOUCH

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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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