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

    TRIA-SONIC ULTRA SOUND TRANSMISSION GEL

    K Number: K901217 · Decision Jun 22, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    8
    Applicant Total
    5
    Review Days
    101

    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
    TRIA-SONIC ULTRA SOUND TRANSMISSION GEL
    K Number
    K901217
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4400
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    H & P Industries, Inc.
    Date Received
    March 13, 1990
    Decision Date
    June 22, 1990
    Product Code
    JOT
    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
    JOT Electrode, Gel, Electrosurgical

    Similar 510(k) Clearances

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

    RFG-DGP DISPOSABLE GROUNDING PADS

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    ULTRASOUND TRANSMISSION GEL

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    ULTRASOUND COUPLING GEL

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    STERILE ULTRASOUND TRANSMISSION GEL

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    ULTRASONIC TRANSMISSION GEL

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    STERILIZED OMNI GEL

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery
    View all

    Other Clearances by H & P Industries, Inc.

    K Number Device Name
    K871169 LUBRICATING JELLY
    K860961 GAMMA RADIATION STERILIZED ALCOHOL PREP PADS
    K830394 PROVIDONE-IODINE PREP-PADS & TOWELETTES
    K830393 PROVIDONE-IODINE SWABSTICKS