# K991178: Flexible Fiberscope, Model 7331.001, Guide Section for Lithovac Handpiece, Model 8708.253

- Pathway: 510(k) (Traditional)
- Applicant: Richard Wolf Medical Instruments Corp.
- Decided: Jun 11, 1999 after 65 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). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980401: Flexible Fiberscopes and Accessories, Richard Wolf Medical Instruments Corp. (1998) Summary page 5.
- K963855: 12 Ureteroscopes/Uretero-Renoscopes, Richard Wolf Medical Instruments Corp. (1997) Summary page 5.

## Indications for use
The flexible fiberscopes are used to examine body cavities and hollow organs via natural accesses or surgically created accesses. For examination, diagnosis, and / or therapy in connection with endoscopic accessories and auxiliary instruments, in particular, for intracorporal flexible lithotripsy probes, e.g., pneumatic or electrohydraulic, used through the working channel of the instrument. The instruments are used in the medical disciplines of urology, surgery, gynecology, and ENT by adequately trained and qualified medical personnel. Applications to the heart, the central nervous system, and the circulatory systems are excluded. Important! Product dimensions must correspond to the anatomic requirements, i.e., use the flexible fiberscope appropriate to the medical discipline.

Source page: https://510kreport.com/device/K991178
Methodology: https://510kreport.com/methodology