# K990050: Uretero-Renoscope, Model 8706.402, Insertion Sheath, Model 8706.042

- Pathway: 510(k) (Traditional)
- Applicant: Richard Wolf Medical Instruments Corp.
- Decided: Mar 26, 1999 after 78 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: 2 generations back to K940464 (1994). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K963855: 12 Ureteroscopes/Uretero-Renoscopes, Richard Wolf Medical Instruments Corp. (1997) Summary page 1.

## Indications for use
The compact operating Uretero-Renoscope 8706.402 is used to examine the ureter and kidney. Various diagnostic and therapeutic procedures can be performed by using additional accessories. + transurethral extraction and lithotripsy of ureteroliths and kidney stones via electrohydraulic, laser, pneumatic, or ultrasonic technology. « tumor diagnostics and / or biopsy + removal of foreign bodies The insertion sleeve, 8706.042 is used as a guide during insertion of the flexible uretero- renoscope and for evacuation of irrigation solution.

Source page: https://510kreport.com/device/K990050
Methodology: https://510kreport.com/methodology