# K963855: 12 Ureteroscopes/Uretero-Renoscopes

- Pathway: 510(k) (Traditional)
- Applicant: Richard Wolf Medical Instruments Corp.
- Decided: Apr 3, 1997 after 190 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: 1 generation back to K940464 (1994). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K940464: Karl Storz Uretero-Renoscope/Ureterscope, KARL STORZ Endoscopy-America, Inc. (1994) Summary page 1.
- (no number) Cysto-Urethroscope 4616: named in the summary without a submission number
- (no number) Cysto-Urethroscope 8616.10: named in the summary without a submission number
- (no number) Ureteroscopes Micro-6 / Micro-6 long: named in the summary without a submission number
- (no number) Operating Ureteroscopes MR-7 Series: named in the summary without a submission number

## Most influential descendants
- K991178: Flexible Fiberscope, Model 7331.001, Guide Section for Lithovac Handpiece, Model 8708.253 (1999), 0 descendants of its own
- K990050: Uretero-Renoscope, Model 8706.402, Insertion Sheath, Model 8706.042 (1999), 0 descendants of its own

## Indications for use
The submitted ureteroscopes and uretero-renoscopes are used to examine the ureter and kidney. Various diagnostic and therapeutic procedures can be performed by using additional accessories, for example disintegration of ureteroliths and kidney stones, biopsy for tumor diagnosis or removal of foreign bodies.

Source page: https://510kreport.com/device/K963855
Methodology: https://510kreport.com/methodology