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

    VISITEC PRECISE-POINT

    K Number: K942234 · Decision Jul 12, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    120
    Registration Numbers
    120
    Same Product Code
    40
    Applicant Total
    49
    Review Days
    64

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    Basic Information

    Device Name
    VISITEC PRECISE-POINT
    K Number
    K942234
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.5030
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Visitec Co.
    Date Received
    May 9, 1994
    Decision Date
    July 12, 1994
    Product Code
    GAP
    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
    GAP Suture, Nonabsorbable, Silk

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    Other Clearances by Visitec Co.

    K Number Device Name
    K953394 VISITEC COLLAR BUTTON CATHETER {GRIFFITHS}
    K945114 VISITEC SCLERAL PLUG
    K945738 VISIFLEX OPHTHALMIC SURGICAL INCISE DRAPE
    K945172 VISITEC SILICONE RETINAL IMPLANTS/EXPLANTS
    K934269 FIBEROPTIC ILLUMINATED INSTRUMENTS
    K940210 VISITEC EYE PAD
    K933872 VISI-SPEAR EYE SPONGE
    K923972 OPHTHALMIC FLUID DISTRIBUTION SETS
    K922530 VISITEC MICROSURGICAL SUTURE
    K923645 VISITEC ASPIRATING SYRINGE
    Search all 49 clearances from Visitec Co. →