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

    NON-BIOABSORBABLE STAPLE

    K Number: K023372 · Decision Dec 27, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    1
    Applicant Total
    5
    Review Days
    80

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    Basic Information

    Device Name
    NON-BIOABSORBABLE STAPLE
    K Number
    K023372
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4495
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Onux Medical, Inc.
    Date Received
    October 8, 2002
    Decision Date
    December 27, 2002
    Product Code
    NJU
    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
    NJU Suture, Nonabsorbable, Nitinol

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (NJU), ordered by most recent decision date.

    COALESCENT U-CLIP- AND ACCESSORIES

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery
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    Other Clearances by Onux Medical, Inc.

    K Number Device Name
    K022777 MANUAL TOUCHE SYSTEM
    K014286 SALUTE, MODEL 3022
    K010620 ENDOSCOPIC STAPLE REMOVAL INSTRUMENT
    K003522 SALUTE