# K060269: Acmi Dur-Digital Ureteroscope and Choledochoscope System

- Pathway: 510(k) (Traditional)
- Applicant: Acmi Corporation
- Decided: Mar 31, 2006 after 58 days
- Product code: FBN (Choledochoscope 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: 6 generations back to K931154 (1993). 21 ancestors in all.
99 later devices descend from it; 7 cite it directly.
2 of 121 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042225: Acmi Invisio Icn, Models Icn-0564 and Icn-0565, Acmi Corporation (2004) Summary page 1.
- K012925: Dur-8, Models Dur-8, Circon Video (2001) Summary page 1.
- K023358: Usa Series Dur 8 Elite, Usa Series Dur 8, Models Dur 8E, Dur 8, Acmi Corporation (2003) Summary page 1.

## Most influential descendants
- 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
- K072594: Gyrus Acmi Ipn-2505, Invisio  Smith Percutaneous  Nephroscope System (2007), 23 descendants of its own
- K092278: Gyrus Acmi Invisio Digital Hysteroscope, Model Idh-4 (2009), 22 descendants of its own

## Indications for use
The ACMI® DUR-Digital Ureteroscope and Choledochoscope (DUR®-D) System (which includes the DUR-Digital Invisio M Flexible Ureteroscope and Choledochoscope and IDC InvisioTM Controller) is intended for use to examine body cavities, hollow organs and canals in the body, in the urinary tract, and can be used percutaneously to examine the interior of the kidney; and, using additional accessories, can be used to perform various diagnostic and therapeutic procedures. The DUR®-D System is also indicated for the examination of bile ducts, and using additional accessories, to perform various diagnostic and therapeutic procedures during cholecystectomy.

Source page: https://510kreport.com/device/K060269
Methodology: https://510kreport.com/methodology