# K182723: Flexible HD Cysto-Urethroscope System

- Pathway: 510(k) (Traditional)
- Applicant: KARL STORZ Endoscopy-America, Inc.
- Decided: Apr 23, 2019 after 207 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: 6 generations back to K931154 (1993). 22 ancestors in all.
3 later devices descend 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)
- K133538: Visera Cysto-Nephro Videoscope Olympus Cyf Type V2, Visera Cysto-Nephro Videoscope Olympus Cyf Type VA2, Visera Cysto-NE, Olympus Corporation of the Americas (2014) Summary page 4.
- K131364: Flexible Cmos-Video-Cysto-Urethroscope, KARL STORZ Endoscopy-America, Inc. (2014) Summary page 4.

## Most influential descendants
- K191357: Flexible HD Cysto-Urethroscope System (2019), 2 descendants of its own
- K202957: Flexible Video Cysto-Urethroscope (C-view) (2020), 1 descendant of its own
- K212476: KARL STORZ Flexible HD Cysto-Urethroscope System (2021), 0 descendants of its own

## Indications for use
The Flexible HD Cysto-Urethroscope System is used to provide visualization and operative access during diagnostic and therapeutic endoscopic procedures of urinary tract including the urethra, bladder, ureters, and kidneys.

Source page: https://510kreport.com/device/K182723
Methodology: https://510kreport.com/methodology