# K960323: Karl Storz  Gelet Uretero-Renoscopes/Karl Storz Alken Motion Control Device

- Pathway: 510(k) (Traditional)
- Applicant: KARL STORZ Endoscopy-America, Inc.
- Decided: Apr 22, 1996 after 90 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Indications for use
The KSEA ‘Gelet’ uretero-renoscopes are designed to view the ureter, and, using additional accessories, to perform various diagnostic and therapeutic procedures. The Alken motion control device attaches to an instrument channel to precisely guide the introduction of a laser fiber, electrode or small instrument into the patient.

Source page: https://510kreport.com/device/K960323
Methodology: https://510kreport.com/methodology