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

    POLYSYN SURGICAL SUTURE

    K Number: K141625 · Decision Jul 18, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    140
    Registration Numbers
    140
    Same Product Code
    147
    Applicant Total
    22
    Review Days
    31

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    Basic Information

    Device Name
    POLYSYN SURGICAL SUTURE
    K Number
    K141625
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    878.4493
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Surgical Specialties Corp
    Date Received
    June 17, 2014
    Decision Date
    July 18, 2014
    Product Code
    GAM
    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
    GAM Suture, Absorbable, Synthetic, Polyglycolic Acid

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    Other Clearances by Surgical Specialties Corp

    K Number Device Name
    K141558 QUILL MONODERM KNOTLESS TISSUE-CLOSURE DEVICE
    K140227 MONODERM SURGICAL SUTURE
    K080985 QUILL SELF-RETAINING SYSTEM (SRS) COMPRISED OF POLYDIOXANONE (PDO)
    K080680 QUILL SELF-RETAINING SYSTEM (SRS) COMPRISED OF PDO (POLYDIOXANONE
    K071989 QUILL SELF-RETAINING SYSTEM (SRS) SYNTHETIC ABSORBABLE SURGICAL SUTURE MATERIAL
    K072028 QUILL SELF-RETAINING SYSTEM (SRS) COMPRISED OF MONODERM
    K063680 SHARPOINT PDO (POLYDIOXANONE) SUTURES
    K053380 CONTOUR THREAD SYNTHETIC ABSORBABLE PDO BARBED SUTURE
    K052962 OPTIMIZED BARB DESIGN
    K052437 MODIFIED MONODERM MONOFILAMENT, SYNTHETIC, ABSORBABLE SUTURE
    Search all 22 clearances from Surgical Specialties Corp →