# K212476: KARL STORZ Flexible HD Cysto-Urethroscope System

- Pathway: 510(k) (Special)
- Applicant: Karl Storz Endoscopy America, Inc.
- Decided: Sep 3, 2021 after 28 days
- Product code: FAJ (Cystoscope And Accessories, Flexible/Rigid)
- 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: 9 generations back to K931154 (1993). 25 ancestors in all.
No later device cites it as a predicate yet.
1 of 26 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191357: Flexible HD Cysto-Urethroscope System, KARL STORZ Endoscopy-America, Inc. (2019) Summary page 4.
- K202957: Flexible Video Cysto-Urethroscope (C-view), KARL STORZ Endoscopy-America, Inc. (2020) Summary page 4.

## Recalls of this device
- Apr 1, 2022 · Class II · Z-1063-2022: Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.

## 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/K212476
Methodology: https://510kreport.com/methodology