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

    Compound W Wart Removal System Dual Power

    K Number: K161294 · Decision Sep 15, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    83
    Registration Numbers
    83
    Same Product Code
    261
    Applicant Total
    9
    Review Days
    129

    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
    Compound W Wart Removal System Dual Power
    K Number
    K161294
    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
    Medtech Products, Inc.
    Date Received
    May 9, 2016
    Decision Date
    September 15, 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 Medtech Products, Inc.

    K Number Device Name
    K242803 Compound W Skin Tag Remover
    K202974 DenTek Fresh Protect Dental Guard
    K180933 DenTek Ultimate Dental Guard
    K172373 Compound W Nitro-Freeze
    K163401 Nix Ultra Lice Treatment Kit
    K853141 ACCESS DIGIWIPE SYSTEM
    K851034 NOVATHERM
    K843601 ACCESS HEMAWIPE