# K260884: UNIDRIVE Select System

- Pathway: 510(k) (Traditional)
- Applicant: Karl Storz SE & CO. KG
- Decided: Sep 1, 2026 after 168 days
- Product code: GCJ (Laparoscope, General & Plastic Surgery)
- 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: 6 generations back to K871250 (1987). 18 ancestors in all.
No later device cites it as a predicate yet.
1 of 19 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192499: Cyber Blade, SIDAM S.r.l. (2020) Summary page 5.

## Indications for use
The UNIDRIVE Select System is intended for cutting and removal of enucleated prostrate tissue from the lower urinary tract in endoscopic interventions.

Source page: https://510kreport.com/device/K260884
Methodology: https://510kreport.com/methodology