CYF
OES CYSTONEPHROFIBERSCOPE - OLYMPUS CYF-5R
Device Description
An endoscope with a flexible inserted portion intended for the visual examination/treatment of the bladder, the urethra (including the prostate region), and the kidneys. It is inserted into the urethra through the natural urinary orifice, and percutaneously into the renal pelvis for the kidneys during an endoscopic procedure. Anatomical images are transmitted to the user by the device through a fibreoptic bundle. This device is commonly used for the removal/crushing of stones, pyelitis, and renal failure (nephroscopy); and treatment of lesions of the urinary bladder/posterior urethra, or to evaluate bladder control/incontinence (cystoscopy). 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:
- High-level Disinfectant
- Ethylene Oxide
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: 04953170328817
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
