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

    Disposable Polyp Snare

    K Number: K220089 · Decision Sep 22, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    63
    Registration Numbers
    63
    Same Product Code
    62
    Applicant Total
    7
    Review Days
    254

    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
    Disposable Polyp Snare
    K Number
    K220089
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.4300
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Jiangsu Vedkang Medical Science and Technology Co., Ltd.
    Date Received
    January 11, 2022
    Decision Date
    September 22, 2022
    Product Code
    FDI
    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
    FDI Snare, Flexible

    Similar 510(k) Clearances

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

    Advanced Tissue Resection Device

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

    Polypectomy Snare

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

    CORE-SNARE

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

    Disposable Polypectomy Snare, Disposable Polypectomy Hybrid Snare

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

    Disposable Polypectomy Snare

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

    SmartBand EMR Kit (SB-EMR-K, SB-EMR-K-12, SB-EMR-K-9.4), SmartBand EMR Pack (SB-EMR-P, SB-EMR-P-12, SB-EMR-P-9.4), SmartSnare EMR Hexagonal Snare (SS-230-1 or packaged with kit)

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

    Other Clearances by Jiangsu Vedkang Medical Science and Technology Co., Ltd.

    K Number Device Name
    K232825 Disposable Sphincterotome
    K232752 Stone Extraction Balloon (VDK-BAL-23-11/13/15-B,VDK-BAL-23-15/18/20-B,VDK-BAL-23-9/12/15-B,VDK-BAL-23-10/13/16-B,VDK-BAL-23-8.5/11.5/15-B,VDK-BAL-23-12/15/18-B,VDK-BAL-23-11/13/15-C,VDK-BAL-23-15/18/20-C,VDK-BAL-23-9/12/15-C,VDK-BAL-23-10/13/16-C,VDK-BAL-23-8.5/11.5/15-C,VDK-BAL-23-12/15/18-C)
    K232245 VedDilator ^TM (3-Stage Balloon Dilation Catheter)
    K230598 Stone Extraction Baskets
    K222146 Disposable Endoscopic Hemoclip
    K213914 Injection Needle