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

    STRAITH NASAL SPLINT

    K Number: K801072 · Decision Jun 17, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    3
    Applicant Total
    12
    Review Days
    42

    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
    STRAITH NASAL SPLINT
    K Number
    K801072
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.3250
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Surgical Technology Laboratories, Inc.
    Date Received
    May 6, 1980
    Decision Date
    June 17, 1980
    Product Code
    FYI
    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
    FYI Appliance, Facial Fracture, External

    Similar 510(k) Clearances

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

    OMEGA BIVALVE NASAL SPLINTS

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

    ETHICON EXTERNAL FIXATION WIRE

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

    CONPHAR O.R. HEAD COVER-STERILE

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

    Other Clearances by Surgical Technology Laboratories, Inc.

    K Number Device Name
    K170582 Saf-T-Vac Smoke and Fluid Evacuator
    K021889 SURGIFORM AUGMENTATION MATERIAL (S.F.A.M.)
    K983755 NASAL DORSAL SERIES
    K983754 STANDARD CHIN
    K983756 SURGIFORM ANATOMICAL MALAR
    K964443 SURGIFORM ANATOMICAL MALAR
    K840835 STRAITH DRAIN INSERTER
    K831078 STRAITH ORAL AIRWAY
    K801074 STRAITH NASAL IMPLANT
    K801073 STRAITH CHIN IMPLANTS
    Search all 12 clearances from Surgical Technology Laboratories, Inc. →