BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇬🇧 United Kingdom

    SPEMBLY MEDICAL 142 CRYO UNIT

    K Number: K882963 · Decision Aug 8, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    83
    Registration Numbers
    83
    Same Product Code
    261
    Applicant Total
    17
    Review Days
    25

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    SPEMBLY MEDICAL 142 CRYO UNIT
    K Number
    K882963
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4350
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Spembly Medical , Ltd.
    Date Received
    July 14, 1988
    Decision Date
    August 8, 1988
    Product Code
    GEH
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    GEH Unit, Cryosurgical, Accessories

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (GEH), ordered by most recent decision date.

    ERBECRYO 2 Cryosurgical Unit and Accessories

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    ERBECRYO 2 Cryosurgical Unit and Accessories: ERBECRYO 2 cryosurgical unit; Erbe Flexible Cryoprobe

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Advanced Cryo Skin Tag Remover (Advanced Skin Tag Remover)

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    XSense Cryoablation System with CryoProbes

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    CoolCryo - Cryoapplicator for cardiac cryoablation (CC01-01); CoolCryo - Control console for cardiac cryoablation with liquid nitrogen reservoir (CC01-21)

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Dr. Yglo Skin Tag Remover

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery
    View all

    Other Clearances by Spembly Medical , Ltd.

    K Number Device Name
    K925129 SELECTOR
    K903303 SPEMBLY MEDICAL 242 CRYOUNIT/SERIES 242 CRYOPROBES
    K901974 SELECTOR ULTRASONIC SURGICAL ASPIRATOR
    K882568 130 CRYO UNIT & ASSOC. CRYOPROBES & SPRAY
    K882962 SERIES 40 & SERIES 42 CRYOPROBES (R SERIES)
    K874367 VARIOUS CARDIAC CRYOPROBES HAVING DIA. & COS. DIFF
    K840497 OBSTETRIC PULSAR TWO CHANNEL TENS
    K832385 CRYOPROBES MC-1400-CRYOSURG-CONSOLE
    K832334 CRYOMEDICS 5000 CRYOSURGICAL CONSOLE
    K832140 CRYOMEDICS 5000 CRYOPROBES
    Search all 17 clearances from Spembly Medical , Ltd. →