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

    O'BRIEN GONIOMETER

    K Number: K926237 · Decision Aug 2, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    83
    Registration Numbers
    83
    Same Product Code
    12
    Applicant Total
    8
    Review Days
    234

    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
    O'BRIEN GONIOMETER
    K Number
    K926237
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    888.1520
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Sgarlato Laboratories, Inc.
    Date Received
    December 11, 1992
    Decision Date
    August 2, 1993
    Product Code
    KQW
    Advisory Committee
    Orthopedic
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    KQW Goniometer, Nonpowered

    Similar 510(k) Clearances

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

    DOBBHOFF(R) RETRIEVAL FORCEPS

    FDA 510(k)
    FDA Class 1 ·Orthopedic

    THE (CROM) TESTER

    FDA 510(k)
    FDA Class 1 ·Orthopedic

    HAND HELD GONIOMETER

    FDA 510(k)
    FDA Class 1 ·Orthopedic

    FINGER BONIOMETER BK7506

    FDA 510(k)
    FDA Class 1 ·Orthopedic

    THE TELOS EQUIPMENT

    FDA 510(k)
    FDA Class 1 ·Orthopedic

    UNIVERSAL GONIMETER

    FDA 510(k)
    FDA Class 1 ·Orthopedic
    View all

    Other Clearances by Sgarlato Laboratories, Inc.

    K Number Device Name
    K043204 SGARLATO LABS PAINFREE PUMP AND PAIN CONTROL INFUSION PUMP
    K990101 PAIN CONTROL INFUSION PUMP
    K982931 THREADED FIXATION PIN
    K926262 FIRST MPJ CONTINUOUS PASSIVE MOTION DEVICE
    K922292 LUNDEEN SUBTALAR PEG IMPLANT
    K905795 SGARLATO FLEXIBLE HINGE TOE IMPLANT
    K884739 SGARLATO LESSER TOE IMPLANT