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

    SMITH & NEPHEW SUTURE COLLET

    K Number: K971939 · Decision Aug 6, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    52
    Registration Numbers
    52
    Same Product Code
    69
    Applicant Total
    18
    Review Days
    71

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    Basic Information

    Device Name
    SMITH & NEPHEW SUTURE COLLET
    K Number
    K971939
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Smith & Nephew Endoscopy, Inc.
    Date Received
    May 27, 1997
    Decision Date
    August 6, 1997
    Product Code
    OCW
    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
    OCW Endoscopic Tissue Approximation Device

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    Other Clearances by Smith & Nephew Endoscopy, Inc.

    K Number Device Name
    K103309 OSTEORAPTOR CURVED 2.3 SUTURE ANCHORS
    K102660 BIORAPTOR CURVED 2.3 PK SUTURE ANCHORS
    K093428 SMITH & NEPHEW KNOTLESS INSTABILITY ANCHOR
    K083635 SMITH & NEPHEW BIOSURE PK INTERFERENCE SCREW
    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
    Search all 18 clearances from Smith & Nephew Endoscopy, Inc. →