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FDA 510(k)

SERIES 40 & SERIES 42 CRYOPROBES (R SERIES)

K-Number: K882962 · 1988-08-08

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

Device Summary

SERIES 40 & SERIES 42 CRYOPROBES (R SERIES) 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 K882962. 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 SERIES 40 & SERIES 42 CRYOPROBES (R SERIES)?

SERIES 40 & SERIES 42 CRYOPROBES (R SERIES) 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 K882962.

When did SERIES 40 & SERIES 42 CRYOPROBES (R SERIES) receive FDA 510(k) clearance?

SERIES 40 & SERIES 42 CRYOPROBES (R SERIES) received FDA 510(k) clearance on 1988-08-08, under 510(k) number K882962.

Who is the listed applicant for SERIES 40 & SERIES 42 CRYOPROBES (R SERIES)?

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 SERIES 40 & SERIES 42 CRYOPROBES (R SERIES)?

The FDA product code for SERIES 40 & SERIES 42 CRYOPROBES (R SERIES) 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 & SPRAYK882963SPEMBLY MEDICAL 142 CRYO UNITK874367VARIOUS CARDIAC CRYOPROBES HAVING DIA. & COS. DIFF

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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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