# K051176: Flexible Video Cystoscope/Choledochoscope, Models 7308.061 and 7308.066

- Pathway: 510(k) (Traditional)
- Applicant: Richard Wolf Medical Instruments Corp.
- Decided: Oct 5, 2005 after 152 days
- Product code: FAJ (Cystoscope 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: 4 generations back to K931154 (1993). 20 ancestors in all.
No later device cites it as a predicate yet.
1 of 21 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980401: Flexible Fiberscopes and Accessories, Richard Wolf Medical Instruments Corp. (1998)
- K021074: Visera Cystovideoscope Olympus Cyf Type V/VA, Olympus America, Inc. (2002) Summary page 1.
- K023659: 1-CCD Endocam 5520 System, Richard Wolf Medical Instruments Corp. (2003) Summary page 1.
- K983279: Endocam Camera Systems 5502 with Electronic CCD Endoscope, Richard Wolf Medical Instruments Corp. (1998) Summary page 1.

## Cited in the summary but kept off the family tree
- K030960: Ecn Electronic Video Cystonephroscope, Acmi Corporation (2003). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Indications for use
The Flexible Video Cystoscope is used for visualizing body cavities and organs via natural passages. For examination, diagnosis and/or therapy in conjunction with endoscopic accessories/ auxiliary instruments through the scope's working channel. The scope is used in the medical disciplines of * Urology (urogenital tract, cystoscopy, nephroscopy) * Surgery (choledochoscopy)

Source page: https://510kreport.com/device/K051176
Methodology: https://510kreport.com/methodology