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

    CUTALON NYLON POLYAMIDE SURGICAL SUTURE

    K Number: K981322 · Decision Jul 7, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    114
    Registration Numbers
    114
    Same Product Code
    56
    Applicant Total
    9
    Review Days
    88

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    Basic Information

    Device Name
    CUTALON NYLON POLYAMIDE SURGICAL SUTURE
    K Number
    K981322
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.5020
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Genzyme Surgical Product (Genzyme Biosurgery)
    Date Received
    April 10, 1998
    Decision Date
    July 7, 1998
    Product Code
    GAR
    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
    GAR Suture, Nonabsorbable, Synthetic, Polyamide

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    Other Clearances by Genzyme Surgical Product (Genzyme Biosurgery)

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    K001440 NEXTSTITCH CARDIOVASCULAR VALVE SUTURE
    K001434 'COTTONY' II DACRON, SILKY II POLYDEK & TEVDEK II POLYESTER NONABSORBABLE SURGICAL SUTURE
    K992088 BONDEK PLUS POLYGLYCOLIC ACID SYNTHETIC ABSORBABLE 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