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

    LANCE LTD. STERI. STITCH CUTTER BLADE

    K Number: K770217 · Decision Mar 30, 1977
    View on FDA
    Classifications
    1
    FEI Numbers
    303
    Registration Numbers
    303
    Same Product Code
    47
    Applicant Total
    5
    Review Days
    56

    Basic Information

    Device Name
    LANCE LTD. STERI. STITCH CUTTER BLADE
    K Number
    K770217
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4800
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    AEROCEUTICALS
    Date Received
    February 2, 1977
    Decision Date
    March 30, 1977
    Product Code
    GES
    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
    GES Blade, Scalpel

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (GES), ordered by most recent decision date.

    PERSONNA PLUS SAFETY SCALPEL SYSTEM

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    EASY-ON

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    LOS ALAMOS RETRACTABLE KNIFE

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    SCALPEL BLADE REMOVER (BLADEGARD)

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    PRECISION GLIDE - ENHANCED SURGICAL BLADE

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    STERILE CARBON STEEL SURGICAL BLADE

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery
    View all

    Other Clearances by AEROCEUTICALS

    K Number Device Name
    K760364 HANDLE, SCALPEL, STAINLESS STEEL
    K760363 SCALPEL, SURGICAL, STERILE STAINLESS
    K760362 LANCET, BLOOD, STERILE STAINLESS STEEL
    K760361 BLADE, SURGICAL SCALPEL, STERILE