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

    RenaFlex Single-use Flexible Ureteroscope (SUURF-V Standard); RenaFlex Single-use Flexible Ureteroscope (SUURF-VR Reverse); Video System Center for Single-use Endoscopes (CV-S1)

    K Number: K233275 · Decision Mar 25, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    120
    Registration Numbers
    120
    Same Product Code
    112
    Applicant Total
    42
    Review Days
    178

    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
    RenaFlex Single-use Flexible Ureteroscope (SUURF-V Standard); RenaFlex Single-use Flexible Ureteroscope (SUURF-VR Reverse); Video System Center for Single-use Endoscopes (CV-S1)
    K Number
    K233275
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Gyrus Acmi, Inc.
    Date Received
    September 29, 2023
    Decision Date
    March 25, 2024
    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 Gyrus Acmi, Inc.

    K Number Device Name
    K252487 POWERSEAL Open Extended Jaw Sealer and Divider, Double-Action (PS-0021EJDA)
    K231327 POWERSEAL Sealer and Divider
    K221306 SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE SuperPulsed Laser Fibers, and Accessories
    K212650 Celeris, Disposable Sinus Debrider
    K213831 Olympus PK Electrosurgical Instruments, PK J-hook, PK Spatula, PK Needle
    K211401 SOLTIVE Laser System (SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories)
    K181696 ChitoZolve
    K180086 Gyrus ACMI – EZDilate 3-Stage Balloon Dilatation Catheter
    K170908 PK AIM
    K163373 PK AIM
    Search all 42 clearances from Gyrus Acmi, Inc. →