BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇪 Germany

    Schoelly Cystoscopes/Hysteroscopes and Accessories

    K Number: K201970 · Decision Oct 8, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    135
    Registration Numbers
    135
    Same Product Code
    170
    Applicant Total
    12
    Review Days
    85

    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
    Schoelly Cystoscopes/Hysteroscopes and Accessories
    K Number
    K201970
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.1690
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Schoelly Fiberoptic GmbH
    Date Received
    July 15, 2020
    Decision Date
    October 8, 2020
    Product Code
    HIH
    Advisory Committee
    Obstetrics/Gynecology
    Review Advisory Committee
    OB
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    HIH Hysteroscope (And Accessories)

    Similar 510(k) Clearances

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

    Strauss Surgical Resection Instruments

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    Manual Tissue Removal Device

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    InnovexView (GC146-17, GC150-20, GC155-23)

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    ARMI® Endoscopic Video Image Processor (JY-MIP-3000); ARMI® Single-Use Hysteroscope (SH-01A, SH-02A, SH-03A, SH-04A, SH-05A, SH-01B, SH-02B, SH-03B, SH-04B, SH-01C, SH-02C, SH-03C, SH-04C)

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    SPY Cystoscope/Hysteroscope

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    RZ Resectoscope System

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology
    View all

    Other Clearances by Schoelly Fiberoptic GmbH

    K Number Device Name
    K233225 SCHOELLY Oxygen Saturation Imaging (OSI) Camera System (Camera Control Unit, Camera Head to be coupled to a fiberoptic scope)
    K221591 Camera System (Camera Control Unit, Camera Head to be coupled to a fiberoptic scope), NIR FI Light Source
    K201617 TipVision Videoscope System (TipVision VideoScope 0°/30°; EleVision HD 2 Camera Control Unit (CCU))
    K151308 Schoelly Nephroscope Set, Schoelly Ultra-Mini Nephroscope Set
    K150158 Schoelly Cystoscopes/Hysteroscopes and Accessories
    K143673 CMOS Video Nasopharyngoscope System
    K142249 SCHOELLY SINUSCOPE
    K143221 Schoelly Laparoscope
    K132009 CMOS VIDEO NASOPHARYNGOSCOPE SYSTEM
    K992362 FLEXISCOPE IQ 101
    Search all 12 clearances from Schoelly Fiberoptic GmbH →