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FDA 510(k)

SPEMBLY MEDICAL 142 CRYO UNIT

K-Number: K882963 · 1988-08-08

ApplicantSpembly Medical , Ltd.
Decision Date1988-08-08
Product CodeGEH
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SPEMBLY MEDICAL 142 CRYO UNIT is the device name listed in this FDA 510(k) record. The listed applicant is Spembly Medical , Ltd.. It received FDA 510(k) clearance on 1988-08-08 under 510(k) number K882963. 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 SPEMBLY MEDICAL 142 CRYO UNIT?

SPEMBLY MEDICAL 142 CRYO UNIT is a medical device that received FDA 510(k) clearance on 1988-08-08. The listed applicant is Spembly Medical , Ltd.. The 510(k) number is K882963.

When did SPEMBLY MEDICAL 142 CRYO UNIT receive FDA 510(k) clearance?

SPEMBLY MEDICAL 142 CRYO UNIT received FDA 510(k) clearance on 1988-08-08, under 510(k) number K882963.

Who is the listed applicant for SPEMBLY MEDICAL 142 CRYO UNIT?

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

What is the FDA product code for SPEMBLY MEDICAL 142 CRYO UNIT?

The FDA product code for SPEMBLY MEDICAL 142 CRYO UNIT is GEH.

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Other records listing Spembly Medical , Ltd. 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.

K925129SELECTORK903303SPEMBLY MEDICAL 242 CRYOUNIT/SERIES 242 CRYOPROBESK901974SELECTOR ULTRASONIC SURGICAL ASPIRATORK882568130 CRYO UNIT & ASSOC. CRYOPROBES & SPRAYK882962SERIES 40 & SERIES 42 CRYOPROBES (R SERIES)K874367VARIOUS CARDIAC CRYOPROBES HAVING DIA. & COS. DIFF

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Related Devices (Code: GEH)

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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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