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

    Flexible Video-Uretero-Renoscope SSU System

    K Number: K212458 · Decision Jan 20, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    120
    Registration Numbers
    120
    Same Product Code
    112
    Applicant Total
    5
    Review Days
    168

    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
    Flexible Video-Uretero-Renoscope SSU System
    K Number
    K212458
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Karl Storz Endoscopy America
    Date Received
    August 5, 2021
    Decision Date
    January 20, 2022
    Product Code
    FGB
    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
    FGB Ureteroscope And Accessories, Flexible/Rigid

    Similar 510(k) Clearances

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

    Single Use Digital Flexible Ureteroscope (7.5F); Videoscope Imaging Processor (Model HV-200)

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

    CVAC Image Processor

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

    Single-use Digital Flexible Ureteroscope (GY-UR9.3); Single-use Digital Flexible Ureteroscope (GY-UR8.4); Single-use Digital Flexible Ureteroscope (GY-UR7.5); Endoscope camera system (GY-AIO-121)

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

    Single-Use Video Flexible Ureterorenoscope (RP-U-C03R9, RP-U-C03R3, RP-U-C03S9, RP-U-C03S3); Endoscopic Video Image Processor (RP-IPD-V2000EF); Endoscopic Video Image Processor (RP-IPD-V1000F)

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

    Miniature Telescope for Urology (27033AA)

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

    Flexible Ureterorenoscope system (Electronic Endoscope Image Processor, model: SP-TXCLQ12.1, Flexible Ureterorenoscope, model: SP-SNGSYJ 2.0, SP-SNGSYJ 2.2, SP-SNGSYJ 2.5, SP-SNGSYJ 2.8)

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

    Other Clearances by Karl Storz Endoscopy America

    K Number Device Name
    K212656 Flexible Intubation Video Endoscope – Sterile (FIVE-S)
    K212695 KARL STORZ ICG Imaging System
    K201001 Modulith SLX-F2
    K201526 TIPCAM1 Rubina Video Endoscope System