# K131364: Flexible Cmos-Video-Cysto-Urethroscope

- Pathway: 510(k) (Traditional)
- Applicant: KARL STORZ Endoscopy-America, Inc.
- Decided: Jan 2, 2014 after 234 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
Longest line of descent: 1 generation back to K945185 (1995). 2 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062918: Karl Storz Flexible Video-Urethro-Cystoscope System, KARL STORZ Endoscopy-America, Inc. (2007) Summary page 1.
- K945185: Cystoscope (78FAJ)Endoscope,Fiberoptic (78GDB), KARL STORZ Endoscopy-America, Inc. (1995) Summary page 1.

## Most influential descendants
- 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-1062-2022: Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.

## Indications for use
The Flexible CMOS Video-Cysto-Urethroscope is used to provide visualization and operative access during diagnostic and therapeutic endoscopic procedures of the lower urinary tract including the bladder and urethra.

Source page: https://510kreport.com/device/K131364
Methodology: https://510kreport.com/methodology