BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    Cryocare CS Surgical System

    K Number: K153489 · Decision Feb 5, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    83
    Registration Numbers
    83
    Same Product Code
    261
    Applicant Total
    3
    Review Days
    63

    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
    Cryocare CS Surgical System
    K Number
    K153489
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4350
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Healthtronics
    Date Received
    December 4, 2015
    Decision Date
    February 5, 2016
    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 Healthtronics

    K Number Device Name
    K151968 Cryocare CS-3 Surgical System version 5
    K141110 CRYOCARE CS SURGICAL SYSTEM