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

    MICRINS NEEDLE HOLDER

    K Number: K872989 · Decision Aug 21, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    241
    Registration Numbers
    241
    Same Product Code
    4
    Applicant Total
    6
    Review Days
    21

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    Basic Information

    Device Name
    MICRINS NEEDLE HOLDER
    K Number
    K872989
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    888.4540
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Applicant
    Micrins Surgical, Inc.
    Date Received
    July 31, 1987
    Decision Date
    August 21, 1987
    Product Code
    HXK
    Advisory Committee
    Orthopedic
    Review Advisory Committee
    OR
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    HXK Holder, Needle; Orthopedic

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    Other Clearances by Micrins Surgical, Inc.

    K Number Device Name
    K993970 MICRINS MICROSURGICAL SUTURE
    K982278 MICRINS MICRO ANASTOMOSIS CLAMP
    K933310 MICRINS CONTRAST BACKGROUND MATERIAL
    K872990 MICRINS SURGICAL SCISSOR
    K872991 MICRINS FORCEPS 2010