# K243409: KARL STORZ Pediatric Cysto-Urethro-Fiberscope (11274BCU1)

- Pathway: 510(k) (Special)
- Applicant: Karl Storz SE & CO. KG
- Decided: Nov 27, 2024 after 26 days
- Product code: FBO (Cystourethroscope)
- 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: 2 generations back to K082046 (2008). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K241945: KARL STORZ Ped. Cysto-Urethro-Fiberscope (11278AC2); KARL STORZ Ped. Cysto-Urethro-Fiberscope (11278ACU1), Karl Storz SE & CO. KG (2024) Summary page 5.

## 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/K243409
Methodology: https://510kreport.com/methodology