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

    ASI HEMOSTASIS CATHETER

    K Number: K901336 · Decision Jun 20, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    83
    Registration Numbers
    83
    Same Product Code
    70
    Applicant Total
    9
    Review Days
    90

    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
    ASI HEMOSTASIS CATHETER
    K Number
    K901336
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5130
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Advanced Surgical Intervention, Inc.
    Date Received
    March 22, 1990
    Decision Date
    June 20, 1990
    Product Code
    GBM
    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
    GBM Catheter, Urethral

    Similar 510(k) Clearances

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

    Wellead® Hydrophilic Intermittent Catheter Ready to Use; Wellead® Hydrophilic Intermittent Catheter Compact

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

    GentleCath Air for Men Hydrophilic Intermittent Urinary Catheter

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

    Intermittent Catheter (Not Finalized)

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

    SpeediCath Compact Set

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

    SpeediCath Compact Set

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

    SpeediCath Soft

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

    Other Clearances by Advanced Surgical Intervention, Inc.

    K Number Device Name
    K954215 MINIGUARD
    K926110 ASI LIGASURE(TM) SUTURE LIGATION INSTRUMENT
    K930361 ASI CYSTOLASE LASER CYSTOSCOPE
    K921990 ASI UROPLASTY LASER CYSTOSCOPE
    K902585 UROPLASTY TCU PROSTATIC URETHROPLASTY CATHETER
    K896713 ASI TCU PROSTATIC URETHROPLASTY CATHETER & ACCESS.
    K895182 ASI CYSTOSCOPE SHEATH, GRASPING FORCEPS & FOR.BODY
    K874530 URETHRAL DILATOR ENDOSCOPE