# K082046: Karl Storz Pediatric Flexible Cysto-Urethro-Fiberscope, Model 11278C1/Acui and Circon Aur-735 Pediatric Cystouretherosco

- Pathway: 510(k) (Traditional)
- Applicant: KARL STORZ Endoscopy-America, Inc.
- Decided: Oct 10, 2008 after 84 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.
2 later devices descend 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)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K241945: KARL STORZ Ped. Cysto-Urethro-Fiberscope (11278AC2); KARL STORZ Ped. Cysto-Urethro-Fiberscope (11278ACU1) (2024), 1 descendant of its own
- K243409: KARL STORZ Pediatric Cysto-Urethro-Fiberscope (11274BCU1) (2024), 0 descendants of its own

## Recalls of this device
- Apr 1, 2022 · Class II · Z-1066-2022: Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.

## Indications for use
The Karl Storz Pediatric Flexible Cysto-Urethro-Fiberscope and accessories are intended used for by a physican in the visual examination and treatment of a variety of urological endoscopic procedures for pediatric patients.

Source page: https://510kreport.com/device/K082046
Methodology: https://510kreport.com/methodology