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

    VISORB SWIFT

    K Number: K023710 · Decision Jan 17, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    140
    Registration Numbers
    140
    Same Product Code
    147
    Applicant Total
    31
    Review Days
    74

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    Basic Information

    Device Name
    VISORB SWIFT
    K Number
    K023710
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4493
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cp Medical
    Date Received
    November 4, 2002
    Decision Date
    January 17, 2003
    Product Code
    GAM
    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
    GAM Suture, Absorbable, Synthetic, Polyglycolic Acid

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    Other Clearances by Cp Medical

    K Number Device Name
    K094028 CP-FIBER (ORTHOFIBER)
    K072229 MONOSWIFT
    K071550 PRE-WAXED NEEDLES WITH GOLD FIDUCIARY MARKERS
    K060987 OSCERA7 SYNTHETIC ABSORBABLE BONE WAX, MODEL OS31
    K041894 ORTHOFIBER
    K034062 CP SLEEVE AND RIVER SLEEVE
    K024372 CP MEDICAL BONE WAX
    K030786 MONO-SWIFT
    K030351 STAINLESS STEEL SURGICAL SUTURE, NON-ABSORBABLE
    K022075 DISPOSABLE TEMPORARY PACING CABLE,MODELS CPW-BV-5,CPW-LG-5,CPW-SM-5,CPW-ERA300-5,CPW-QLOC-5
    Search all 31 clearances from Cp Medical →