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

    BONDEK PLUS POLYGLYCOLIC ACID SYNTHETIC ABSORBABLE SURGICAL SUTURE

    K Number: K992088 · Decision Sep 3, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    140
    Registration Numbers
    140
    Same Product Code
    147
    Applicant Total
    9
    Review Days
    74

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    Basic Information

    Device Name
    BONDEK PLUS POLYGLYCOLIC ACID SYNTHETIC ABSORBABLE SURGICAL SUTURE
    K Number
    K992088
    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
    Genzyme Surgical Product (Genzyme Biosurgery)
    Date Received
    June 21, 1999
    Decision Date
    September 3, 1999
    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 Genzyme Surgical Product (Genzyme Biosurgery)

    K Number Device Name
    K001440 NEXTSTITCH CARDIOVASCULAR VALVE SUTURE
    K001434 'COTTONY' II DACRON, SILKY II POLYDEK & TEVDEK II POLYESTER NONABSORBABLE SURGICAL SUTURE
    K991416 ENDOSCOPIC CAMERA
    K991191 BONDEK POLYGLYCOLIC ACID SYNTHETIC ABSORBABLE SURGICAL SUTURE
    K990062 SAPHLIFT
    K982712 RAPID TRANSFER BLOOD BAG MODEL A-1650, RAPID TRANSFER BLOOD BAG MODEL S-250
    K980016 MILLENNIUM VALVE INTRODUCER/ROTATOR HANDLE
    K981322 CUTALON NYLON POLYAMIDE SURGICAL SUTURE