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

    CIRCON ACMI BICAP HEMORRHOID SYSTEM BH-10 & BHP-20

    K Number: K884252 · Decision Jan 10, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    117
    Registration Numbers
    117
    Same Product Code
    187
    Applicant Total
    10
    Review Days
    91

    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
    CIRCON ACMI BICAP HEMORRHOID SYSTEM BH-10 & BHP-20
    K Number
    K884252
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.4300
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Circon Acmi
    Date Received
    October 11, 1988
    Decision Date
    January 10, 1989
    Product Code
    KNS
    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
    KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories)

    Similar 510(k) Clearances

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

    Sphincterotome

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

    Vanquish Water Vapor Ablation Device

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

    Single Use 3-Lumen Needle Knife V (KD-V441M, KD-V451M)

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

    Single Use Preloaded Sphincterotome V (Distal Wire Guided) (KD-VC600 Series); Single Use Sphincterotome V (Distal Wire Guided) (KD-VC400 Series); Single Use 3-Lumen Sphincterotome (KD-V Series); Disposable Triple Lumen Sphincterotome (KD Series)

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

    Single Use Electrosurgical Knife (KD-612L, KD-612U); Single Use Electrosurgical Knife (KD-620UR); Single Use Electrosurgical Knife (KD-650L, KD-650U)

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

    SureTome™ SW Sphincterotome with DomeTip

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

    Other Clearances by Circon Acmi

    K Number Device Name
    K013165 USA SERIES LAPAROSCOPES
    K980492 AEH-3 ELECTROHYDRAULIC LITHOTRIPTER AND PROBES (E-1F, E-3F, E-5F, AND E-9F)
    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
    K884306 BICAP ABLATING FORCEPS BAF-7
    K883819 BULLARD INTUBATING LARYNGOSCOPE LAR-A & LAR-P