# K253411: Miniature Telescope for Urology (27033AA)

- Pathway: 510(k) (Traditional)
- Applicant: Karl Storz SE & CO. KG
- Decided: Nov 18, 2025 after 49 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: 2 generations back to K940464 (1994). 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)
- K233372: KARL STORZ Fiber Telescopes for Urology, Karl Storz SE & CO. KG (2024) Summary page 5.
- K940464: Karl Storz Uretero-Renoscope/Ureterscope, KARL STORZ Endoscopy-America, Inc. (1994) Summary page 5.

## Indications for use
The endoscopes when used with sheaths and obturators are intended to provide visualization of the operative site during minimal invasive urological endoscopic procedures in adults and pediatrics.

Source page: https://510kreport.com/device/K253411
Methodology: https://510kreport.com/methodology