# K244001: KARL STORZ Cysto-Urethro-Fiberscope (11272CU1); KARL STORZ Cysto-Urethro-Fiberscope (11272C2)

- Pathway: 510(k) (Traditional)
- Applicant: Karl Storz SE & CO. KG
- Decided: May 2, 2025 after 127 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: 1 generation back to K945185 (1995). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K945185: Cystoscope (78FAJ)Endoscope,Fiberoptic (78GDB), KARL STORZ Endoscopy-America, Inc. (1995) Summary page 5.

## Indications for use
The KARL STORZ Cysto-Urethro-Fiberscope and accessories are indicated for visualization and operative access during diagnostic and therapeutic endoscopic procedures of the urinary tract including the urethra and bladder.

Source page: https://510kreport.com/device/K244001
Methodology: https://510kreport.com/methodology