# K183188: Flexible Sensor-Ureterorenoscopes BOA Vision EF, Flexible Sensor-Ureterorenoscopes COBRA Vision EF

- Pathway: 510(k) (Traditional)
- Applicant: Richard Wolf Medical Instruments Corporation
- Decided: May 3, 2019 after 165 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: 8 generations back to K931154 (1993). 24 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 26 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131369: Flexible Video-Uretero-Renoscope System, KARL STORZ Endoscopy-America, Inc. (2013) Summary page 4.

## Most influential descendants
- K201897: Sensor-Ureterorenoscope 9 FR WL 600 MM (short RIWO D-URS), Adapter For Controller 5525 (2021), 0 descendants of its own

## Indications for use
The Flexible Sensor-Ureterorenoscopes BOA Vision EF and Flexible Sensor-Ureterorenoscopes COBRA Vision EF are used for visualizing body cavities and organs via natural and surgically created passages. These products are exclusively intended for use by specialized medical personnel and must only be used by medically qualified and adequately instructed persons. For examination, diagnostics and/or therapy in conjunction with endoscopic accessories. The product is used in the following disciplines: Urology: - Urogenital tract - Nephroscopy

Source page: https://510kreport.com/device/K183188
Methodology: https://510kreport.com/methodology