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

    AEH-3 ELECTROHYDRAULIC LITHOTRIPTER AND PROBES (E-1F, E-3F, E-5F, AND E-9F)

    K Number: K980492 · Decision Nov 17, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    36
    Registration Numbers
    36
    Same Product Code
    60
    Applicant Total
    10
    Review Days
    281

    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
    AEH-3 ELECTROHYDRAULIC LITHOTRIPTER AND PROBES (E-1F, E-3F, E-5F, AND E-9F)
    K Number
    K980492
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.4480
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Circon Acmi
    Date Received
    February 9, 1998
    Decision Date
    November 17, 1998
    Product Code
    FFK
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    FFK Lithotriptor, Electro-Hydraulic

    Similar 510(k) Clearances

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

    Electrohydraulic Lithotriptor (TCS-B3-II)

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    EHL Probe (SCDG-AS); EHL Probe (SCDG-BS); EHL Probe (SCDG-CS)

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    EL27-Compact; Sterile EHL-Probes

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    URO-TOUCH 9 French Probe

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Swiss LithoClast Trilogy

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    UreTron PF Series Probe

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology
    View all

    Other Clearances by Circon Acmi

    K Number Device Name
    K013165 USA SERIES LAPAROSCOPES
    K905706 GYN-1500 HYSTEROSCOPIC INUFFLATOR
    K905705 LAP 3501 HIGH FLOW INSUFFLATOR
    K884097 MORRIS ANTI-SPLATTER DEVICE FOR ENDOSCOPES
    K884025 CIRCON ACMI BICAP II THERAPEUTIC SYSTEM BC-200
    K884254 CIRCON ACMI BICAP III THERAPEUTIC SYSTEM
    K884252 CIRCON ACMI BICAP HEMORRHOID SYSTEM BH-10 & BHP-20
    K884306 BICAP ABLATING FORCEPS BAF-7
    K883819 BULLARD INTUBATING LARYNGOSCOPE LAR-A & LAR-P