# K062918: Karl Storz Flexible Video-Urethro-Cystoscope System

- Pathway: 510(k) (Traditional)
- Applicant: KARL STORZ Endoscopy-America, Inc.
- Decided: Jan 17, 2007 after 111 days
- Product code: FBO (Cystourethroscope)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
5 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K131364: Flexible Cmos-Video-Cysto-Urethroscope (2014), 4 descendants of its own
- K182723: Flexible HD Cysto-Urethroscope System (2019), 3 descendants of its own
- 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

## Recalls of this device
- Apr 1, 2022 · Class II · Z-1064-2022: Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.

## Indications for use
The Karl Storz Video-Urethro-Cystoscope System is intended for use by physicians in the visual examination and treatment of a variety of urological endoscopic procedures. The Video-Urethro-Cystoscope is intended to provide optical visualization via a video monitor and therapeutic access.

Source page: https://510kreport.com/device/K062918
Methodology: https://510kreport.com/methodology