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

    BORES* DEPTH GAUGE

    K Number: K812069 · Decision Aug 31, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    398
    Registration Numbers
    398
    Same Product Code
    22
    Applicant Total
    8
    Review Days
    41

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    BORES* DEPTH GAUGE
    K Number
    K812069
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4800
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Santa Barbara Medco, Inc.
    Date Received
    July 21, 1981
    Decision Date
    August 31, 1981
    Product Code
    FTY
    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
    FTY Tape, Measuring, Rulers And Calipers

    Similar 510(k) Clearances

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

    Noxilizer Surgical Ruler

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

    DISPOSABLE WOUND MEASURE GUIDE, PLASTIC, PROTECTOR, WOUND, PLASTIC

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

    OLYMPIC AUTO-LENGTH

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

    OLYMPIC INFA-LENGTH

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

    STRYKER PRESSURE MONITOR SYSTEM

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

    PEDIATRIC AIRWAY MEASUREMENT SYSTEM & P.A.M.S.

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

    Other Clearances by Santa Barbara Medco, Inc.

    K Number Device Name
    K850492 NASAL SEPTAL BUTTON
    K842483 SANTA BARBARA MEDCO-LANTOPHORETIC APPLIC
    K823921 PHYSICIANS CHOICE SILICONE EAR PUTTY
    K821187 MEDCO CUSTOM EAR PROTECTOR MOLD KIT
    K812071 RK IV SURGICAL BLADES
    K812070 BORES* ADJUSTABLE BLADE HOLDER
    K802638 OTOLOGICAL VENTILATION TUBES