BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    SUTURE LOCK

    K Number: K964935 · Decision Feb 25, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    88
    Registration Numbers
    88
    Same Product Code
    19
    Applicant Total
    18
    Review Days
    77

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    Basic Information

    Device Name
    SUTURE LOCK
    K Number
    K964935
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4930
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Smith & Nephew Endoscopy, Inc.
    Date Received
    December 10, 1996
    Decision Date
    February 25, 1997
    Product Code
    KGS
    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
    KGS Retention Device, Suture

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    Other Clearances by Smith & Nephew Endoscopy, Inc.

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    K093428 SMITH & NEPHEW KNOTLESS INSTABILITY ANCHOR
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    K083226 SMITH & NEPHEW PEEK INTERFERENCE SCREW
    K082095 ULTRASLIDE ACROMIOCLAVICULAR AND SYNDESMOTIC REPAIR DEVICE
    K050580 SMITH & NEPHEW INTELIJET FLUID MANAGEMENT SYSTEMS
    K992396 BIORCI SCREW
    K991500 SMITH & NEPHEW SUTURE LOK
    K972599 ACUFEX SCREW CANNULA
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