BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    Balloon Dilatation Catheter

    K Number: K213578 · Decision Apr 6, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    77
    Registration Numbers
    77
    Same Product Code
    111
    Applicant Total
    17
    Review Days
    147

    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
    Balloon Dilatation Catheter
    K Number
    K213578
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Hangzhou AGS MedTech Co., Ltd.
    Date Received
    November 10, 2021
    Decision Date
    April 6, 2022
    Product Code
    FDF
    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
    FDF Colonoscope And Accessories, Flexible/Rigid

    Similar 510(k) Clearances

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

    Disposable Endoscopic Distal Attachments

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

    Disposable Distal End Tape Hood

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

    ROBOPERA (ER-R-002); ROBOPERA (ER-R-003)

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

    FUJIFILM Endoscope Model EC-860P/M; FUJIFILM Endoscope Model EC-860P/L; FUJIFILM Endoscope Model EC-860S/L

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

    Colonovideoscope (CF-EZ1500DL); Colonovideoscope (CF-EZ1500DI); Gastrointestinal Videoscope (GIF-EZ1500)

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

    PENTAX Medical Video Colonoscope (EC38-i20cWL)

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

    Other Clearances by Hangzhou AGS MedTech Co., Ltd.

    K Number Device Name
    K252270 Hemoclip
    K252271 Hemoclip
    K241704 Endoscopic Water Pump
    K222421 Sphincterotome
    K221713 Polypectomy Snare
    K213143 Hemoclip
    K211787 Hemoclip
    K210406 Bipolar Coagulation Foreceps
    K201121 Sphincterotome
    K202237 Locking device
    Search all 17 clearances from Hangzhou AGS MedTech Co., Ltd. →