# K012925: Dur-8, Models Dur-8

- Pathway: 510(k) (Traditional)
- Applicant: Circon Video
- Decided: Nov 7, 2001 after 68 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.
102 later devices descend from it; 2 cite it directly.
1 of 103 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K023358: Usa Series Dur 8 Elite, Usa Series Dur 8, Models Dur 8E, Dur 8 (2003), 101 descendants of its own
- K060269: Acmi Dur-Digital Ureteroscope and Choledochoscope System (2006), 99 descendants of its own
- K131369: Flexible Video-Uretero-Renoscope System (2013), 53 descendants of its own
- K153049: LithoVue System (2015), 24 descendants of its own
- K172098: Medical Video Endoscope System (2017), 23 descendants of its own

## Indications for use
The intended use for this device is for therapeutic and diagnostic procedures in the entire intrarenal collecting system. These devices are marketed as reusable devices. The methods for cleaning, disinfection, and sterilization are presented in “Sterility Information," Section 5 of this document.

Source page: https://510kreport.com/device/K012925
Methodology: https://510kreport.com/methodology