# K012951: Apn-2 Usa Series Flexible Choledochoscope

- Pathway: 510(k) (Traditional)
- Applicant: Circon Video
- Decided: Nov 9, 2001 after 66 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.
106 later devices descend from it; 2 cite it directly.
1 of 107 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
- K030960: Ecn Electronic Video Cystonephroscope (2003), 103 descendants of its own
- K042225: Acmi Invisio Icn, Models Icn-0564 and Icn-0565 (2004), 101 descendants of its own
- 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

## Indications for use
The CIRCON ACMI USA Series™ APN-2 Flexible Choledochoscope may be used in the biliary tract for diagnostic and therapeutic treatment of ductal stones during laparoscopic cholecystectomy.

Source page: https://510kreport.com/device/K012951
Methodology: https://510kreport.com/methodology