# K201897: Sensor-Ureterorenoscope 9 FR WL 600 MM (short RIWO D-URS), Adapter For Controller 5525

- Pathway: 510(k) (Traditional)
- Applicant: Richard Wolf Medical Instruments Corporation
- Decided: Jan 15, 2021 after 191 days
- Product code: FGB (Ureteroscope And Accessories, Flexible/Rigid)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K931154 (1993). 25 ancestors in all.
No later device cites it as a predicate yet.
1 of 26 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K183188: Flexible Sensor-Ureterorenoscopes BOA Vision EF, Flexible Sensor-Ureterorenoscopes COBRA Vision EF, Richard Wolf Medical Instruments Corporation (2019) Summary page 4.

## Indications for use
Sensor-Ureterorenoscopes are used within the scope of therapeutic and diagnostic interventions. The products are active, sterile and for single-use. They are used for visualizing body cavities via natural passages and for the insertion of auxiliary instruments through the working channel as well as the supply of irrigation fluid. The Sensor-Ureterorenoscope is used in Urology for examination, diagnostics and/or therapy of the upper urinary tract. These products are exclusively intended for use by specialized medical personnel and must only be used by medically qualified and adequately instructed persons. The products are used for operating a sensor endoscope in conjunction with an ENDOCAM Logic 5525 Camera Controller, for the mechanical connection to the sensor endoscope as well as for controlling the signals generated. This product is designed exclusively for use by specialized medical personnel and may only be applied by medically qualified and adequately trained persons.

Source page: https://510kreport.com/device/K201897
Methodology: https://510kreport.com/methodology