FIBER OPTIC CYSTOSCOPE 2.2C 4.8TP 400L (REFURBISHED)


Product Overview

FIBER OPTIC CYSTOSCOPE 2.2C 4.8TP 400L (REFURBISHED)
FIBER CYTOSCOPE - FCY-15P2


Device Description

An endoscope with a flexible inserted portion intended for the visual examination and treatment of the bladder and the urinary tract. It is inserted into the urethra (the tube that carries urine from the bladder to the outside of the body) through the natural urinary orifice during cystoscopy. Anatomical images are transmitted to the user by the device through a fibreoptic bundle. This device is commonly used to examine/diagnose incontinence, the inability to pass urine (retention), recurrent urinary tract infections, and to remove tissue samples/stones/small tumours from the bladder. This is a reusable device.


Environmental Conditions

No Data Available


Device Sizes

No Data Available


Device Sterilization

Device Sterile: False

Sterilization Prior To Use: True

Sterilization Methods:

  • Ethylene Oxide
  • High-level Disinfectant
    • Ethylene Oxide
    • High-level Disinfectant


    Product Codes

    Code: FAJ

    Device Name: Cystoscope And Accessories, Flexible/Rigid

    Device Class: 2

    Physical State: endoscope, accessories associated with cystoscope

    Definition: To examine and perform procedures within the urinary tract. For reusable, flexible endoscopes in this product code, validated reprocessing instructions and reprocessing validation data must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

    Submission Type ID: 1

    Review Panel: GU

    Review Code: N/A

    Technical Method: N

    Gmp Exempt Flag: Intrument guided through urethra for visualization and to perform various procedures.

    Life Sustain Support Flag: N

    Unclassified Reason: N/A

    Implant Flag: N

    Target Area: bladder, urethra, kidneys

    Regulation Number: 876.1500

    Third Party Flag: N

    Medical Specialty: GU


    Device Identifiers

    Device Id: 04961333232734

    Device Type: Primary

    DeviceId Issuing Agency: GS1

    Contains DI Number: N/A

    Package Quantity: N/A

    Package Discontinue Date: N/A

    Package Status: N/A

    Package Type: N/A


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