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

    POS-T-VAC (REJOYN VACUUM ERECTION DEVICE)

    K Number: K981011 · Decision Aug 28, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    49
    Registration Numbers
    49
    Same Product Code
    86
    Applicant Total
    12
    Review Days
    163

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    Basic Information

    Device Name
    POS-T-VAC (REJOYN VACUUM ERECTION DEVICE)
    K Number
    K981011
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5020
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Pos-T-Vac, Inc.
    Date Received
    March 18, 1998
    Decision Date
    August 28, 1998
    Product Code
    LKY
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    LKY Device, External Penile Rigidity

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    Other Clearances by Pos-T-Vac, Inc.

    K Number Device Name
    K020258 SUPPORT SLEEVE
    K020154 VT-1
    K012670 BOSS 2000-3 VACUUM ERECTION DEVICE
    K012672 BOSS-2000-2 VACUUM ERECTION DEVICE
    K983246 POS-T-VAC (IVP-600)
    K983245 POS-T-VAC (AVP-1000)
    K981180 REJOYN CONSTRICTION RING KIT, POS-T-VAC B-100 RING KIT, POS-T-VAC B-25 RING KIT AND POS-T-VAC B-10 RING KIT
    K961309 POS-T-VAC ID-300
    K960828 POS-T-VAC B-10 BAND KIT
    K960342 POS-T-VAC AVP-1000 & MVP-700
    Search all 12 clearances from Pos-T-Vac, Inc. →