# K243653: KARL STORZ HOPKINS Telescopes for Urology

- Pathway: 510(k) (Traditional)
- Applicant: Karl Storz SE & CO. KG
- Decided: Aug 13, 2025 after 260 days
- Product code: FAJ (Cystoscope 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 K943176 (1994). 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)
- K943176: Karl Storz Hopkins I&II/Oper/Autoclavable Telescopesq, KARL STORZ Endoscopy-America, Inc. (1994) Summary page 5.

## Indications for use
Telescopes for adults KARL STORZ HOPKINS Telescopes for Urology when used with sheaths, obturators, accessories, and instruments are intended to provide visualization and operative access during diagnostic and therapeutic urological procedures in adults. Telescopes for adults and pediatrics KARL STORZ HOPKINS Telescopes for Urology when used with sheaths, obturators, accessories, and instruments are intended to provide visualization and operative access during diagnostic and therapeutic urological procedures in adults and pediatrics.

Source page: https://510kreport.com/device/K243653
Methodology: https://510kreport.com/methodology