BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

    CYSTOSCOPE, MODELS CE0004-C, CE006-C, CE3004-C, CE3027-C, CE7004-C, CE1204-C, CE1227-C

    K Number: K093725 · Decision Aug 30, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    136
    Registration Numbers
    136
    Same Product Code
    91
    Applicant Total
    1
    Review Days
    270

    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
    CYSTOSCOPE, MODELS CE0004-C, CE006-C, CE3004-C, CE3027-C, CE7004-C, CE1204-C, CE1227-C
    K Number
    K093725
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Canada Endoscope Corporation
    Date Received
    December 3, 2009
    Decision Date
    August 30, 2010
    Product Code
    FAJ
    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
    FAJ Cystoscope And Accessories, Flexible/Rigid

    Similar 510(k) Clearances

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

    OES ELITE Cystoscope and Accessories; Obturator, 17 Fr. (WA2C17BO); Obturator, 19.8 Fr. (WA2C19BO); Obturator, 21 Fr. (WA2C21BO); Obturator, 21 Fr., for sheath with ramp (WA2C21RO); Obturator, 21 Fr., long (WA2C21LO); Obturator, 21 Fr., for straight sheath (WA2C21SO); Obturator, 22.5 Fr. (WA2C22BO); Obturator, 25 Fr. (WA2C25BO); Obturator, optical, 19.8 Fr. (WA2C19BV); Obturator, optical, 21 Fr. (WA2C21BV); Obturator, optical, 21 Fr., for straight sheath (WA2C21SV); Obturator, optical,

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

    CFlex Cystoscope - Standard Deflection (0570-0455); CFlex Cystoscope - Reverse Deflection (0570-0456); CystoView Monitor (0570-0465)

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

    Strauss Surgical Cystoscopes & Hysteroscopes (STS-2040-302ASA HD-endoscope, 4 x 302 mm, view. Dir. 0°, standard, autoclavable); Strauss Surgical Cystoscopes & Hysteroscopes (STS-2040-302AA HD-endoscope, 4 x 302 mm, view. Dir. 0°, wide angle, autoclavable); Strauss Surgical Cystoscopes & Hysteroscopes (STS-2040-302BA HD-endoscope, 4 x 302 mm, view. Dir. 30°, wide angle, autoclavable); Strauss Surgical Cystoscopes & Hysteroscopes (STS-2040-302BSA HD-endoscope, 4 x 302 mm, view. Dir. 30°,

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

    PrimeSight UltraView System

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

    Strauss Surgical cystoscope, hysteroscope and accessories Instruments

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

    UV5000W Handle

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