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

    LAP 3501 HIGH FLOW INSUFFLATOR

    K Number: K905705 · Decision Feb 28, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    141
    Registration Numbers
    141
    Same Product Code
    176
    Applicant Total
    10
    Review Days
    66

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    Basic Information

    Device Name
    LAP 3501 HIGH FLOW INSUFFLATOR
    K Number
    K905705
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.1730
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Applicant
    Circon Acmi
    Date Received
    December 24, 1990
    Decision Date
    February 28, 1991
    Product Code
    HIF
    Advisory Committee
    Obstetrics/Gynecology
    Review Advisory Committee
    OB
    Third Party
    N

    Classifications

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

    Product Code Device Name
    HIF Insufflator, Laparoscopic

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    Other Clearances by Circon Acmi

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    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