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FDA 510(k)

CMS CRYOLITE

K-Number: K970995 · 1997-07-07

ApplicantCryomedical Sciences, Inc.
Decision Date1997-07-07
Product CodeGEH
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CMS CRYOLITE is the device name listed in this FDA 510(k) record. The listed applicant is Cryomedical Sciences, Inc.. It received FDA 510(k) clearance on 1997-07-07 under 510(k) number K970995. 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 CMS CRYOLITE?

CMS CRYOLITE is a medical device that received FDA 510(k) clearance on 1997-07-07. The listed applicant is Cryomedical Sciences, Inc.. The 510(k) number is K970995.

When did CMS CRYOLITE receive FDA 510(k) clearance?

CMS CRYOLITE received FDA 510(k) clearance on 1997-07-07, under 510(k) number K970995.

Who is the listed applicant for CMS CRYOLITE?

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

What is the FDA product code for CMS CRYOLITE?

The FDA product code for CMS CRYOLITE is GEH.

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Other records listing Cryomedical Sciences, 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.

K011073CRYOPLAN SYSTEMK982055ACCUPROBE 800 SERIES MODEL NUMBERS : 810, 820, 830, 840, 850, 860, 870 AND 880K980668CMS BLIZZARD 700 SERIES MODELS 730, 740,750,760,770,780 & 790K980670CMS BLIZZARD 700 SERIES MODELS 710, 711, 712, 720, 721 AND 722K973190ACCUPROBE 450, ACCUPROBE 550/530 AND THE ACCUPROBE 600 SERIESK964336CMS ACCUPROBE 610, 620, 630, 640, 650, 660, 670, 680

View all 10 devices →

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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