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

    SSC'S PCL MONOFILAMENT SAS, VIOLET, COATED, MODEL TBD

    K Number: K003015 · Decision Dec 15, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    29
    Registration Numbers
    29
    Same Product Code
    6
    Applicant Total
    22
    Review Days
    79

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    Basic Information

    Device Name
    SSC'S PCL MONOFILAMENT SAS, VIOLET, COATED, MODEL TBD
    K Number
    K003015
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4830
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Surgical Specialties Corp
    Date Received
    September 27, 2000
    Decision Date
    December 15, 2000
    Product Code
    GAN
    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
    GAN Suture, Absorbable, Synthetic

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    Other Clearances by Surgical Specialties Corp

    K Number Device Name
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    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
    Search all 22 clearances from Surgical Specialties Corp →