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

    NEOSCOPE - ENDOSCOPIC DIAGNOSTIC & TREATMENT SYSTEM

    K Number: K042780 · Decision Feb 3, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    136
    Registration Numbers
    136
    Same Product Code
    91
    Applicant Total
    16
    Review Days
    120

    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
    NEOSCOPE - ENDOSCOPIC DIAGNOSTIC & TREATMENT SYSTEM
    K Number
    K042780
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Prosurg, Inc.
    Date Received
    October 6, 2004
    Decision Date
    February 3, 2005
    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

    Other Clearances by Prosurg, Inc.

    K Number Device Name
    K152511 Neo - Arthroscope (Rigid) 2.0mm/3.5mm, Outer sheath/ cannula, Outer sheath/ cannula w/ Handle, Trocar for outersheath/ cannula
    K152466 Neo-Bronchoscope -Digital Video Bronchoscopy System(Rigid/Flexible)
    K152619 Neoscope 3D - 3D Digital Video Endoscopic System (Rigid/Flexible)
    K120766 ENDOSCOPIC DIAGNOSTIC & TREATMENT SYSTEM (MODIFICATION)
    K072528 ADJUSTABLE BONE PLATES BIOABSORBABLE, SELF COMPRESSION BONE FIXATION SYSTEM & ACCESSORIES
    K071138 CRANIOCLAMP BIOABSORBABLE CRANIAL BONE FLAP FIXATION SYSTEM
    K070737 XSORB BIOABSORBABLE CRANIOFACIAL BONE FIXATION SYSTEM & ACCESSORIES
    K070846 MINISLING ADJUSTABLE POLYMER SLING & SURGICAL MESH WITH SELF-ANCHORING SYSTEM
    K060326 LASERTX - DIODE LASER & DELIVERY SYSTEM
    K050488 TURBT-RF ELECTRODES AND ELECTROSURGICAL DEVICES
    Search all 16 clearances from Prosurg, Inc. →