# K241945: KARL STORZ Ped. Cysto-Urethro-Fiberscope (11278AC2); KARL STORZ Ped. Cysto-Urethro-Fiberscope (11278ACU1)

- Pathway: 510(k) (Special)
- Applicant: Karl Storz SE & CO. KG
- Decided: Aug 1, 2024 after 29 days
- Product code: FGB (Ureteroscope 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: 1 generation back to K082046 (2008). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082046: Karl Storz Pediatric Flexible Cysto-Urethro-Fiberscope, Model 11278C1/Acui and Circon Aur-735 Pediatric Cystouretherosco, KARL STORZ Endoscopy-America, Inc. (2008) Summary page 6.

## Most influential descendants
- K243409: KARL STORZ Pediatric Cysto-Urethro-Fiberscope (11274BCU1) (2024), 0 descendants of its own

## Indications for use
The KARL STORZ Pediatric Cysto-Urethro-Fiberscope and accessories are intended for use by a physician in the visual examination and treatment of a variety of urological endoscopic procedures for pediatric patients.

Source page: https://510kreport.com/device/K241945
Methodology: https://510kreport.com/methodology