BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇯🇵 Japan

    Disposable Balloon Catheter (B5-2Q); Disposable Balloon Catheter (B7-2Q); Disposable Balloon Catheter (B7-2LA)

    K Number: K250409 · Decision Oct 21, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    143
    Registration Numbers
    143
    Same Product Code
    473
    Applicant Total
    81
    Review Days
    250

    Basic Information

    Device Name
    Disposable Balloon Catheter (B5-2Q); Disposable Balloon Catheter (B7-2Q); Disposable Balloon Catheter (B7-2LA)
    K Number
    K250409
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5010
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Olympus Medical Systems Corporation
    Date Received
    February 13, 2025
    Decision Date
    October 21, 2025
    Product Code
    FGE
    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
    FGE Stents, Drains And Dilators For The Biliary Ducts

    Similar 510(k) Clearances

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

    Dilation Balloon Catheter

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

    Endoflux™ Biliary & Pancreatic Stent Sets

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

    BARE Wireguided Balloon Dilation Catheter (1235)

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

    Single use stone retrieval balloons

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

    Niti-S Biliary Stent; Niti-S Biliary Slim M Stent

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

    BIOTEQ Drainage Catheter Set: BT-PD1-SERIES-G and BT-PDS-SERIES-G

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

    Other Clearances by Olympus Medical Systems Corporation

    K Number Device Name
    K252050 Disposable Biopsy Forceps FB-211D, FB-221D, FB-231D, FB-241D
    K250993 Single Use Cytology Brush V (BC-V600P-3010)
    K252889 Single Use 3-Lumen Needle Knife V (KD-V441M, KD-V451M)
    K252247 Injector Force Max Single Use Injector (NM-400L); Injector Force Max Single Use Injector (NM-400U); Injector Force Max Single Use Injector (NM-400Y); Injector Force Max Single Use Injector (NM-401L)
    K250351 Single Use Electrosurgical Knife (KD-612L, KD-612U); Single Use Electrosurgical Knife (KD-620UR); Single Use Electrosurgical Knife (KD-650L, KD-650U)
    K252150 Ultrasonic Bipolar Generator (USG-410); Reuseable Cordless Transducer (TD-410); THUNDERBEAT II Shears with Ultrasonic Mode, 5mm, 45cm (TB2-0545FC); THUNDERBEAT II Shears with Ultrasonic Mode, 5mm, 35cm (TB2-0535FC); THUNDERBEAT II Shears with Ultrasonic Mode, 5mm, 25cm (TB2-0525FC); THUNDERBEAT II Shears with Ultrasonic Mode, 5mm, 20cm (TB2-0520FC)
    K250187 Disposable Hot Biopsy Forceps (FD-210U); Disposable Hot Biopsy Forceps (FD-230U)
    K251859 EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190)
    K251986 AUXILIARY WATER TUBE MAJ-855
    K251997 Single-Use Biopsy Valve (MAJ-1555)
    Search all 81 clearances from Olympus Medical Systems Corporation →