# K951191: FCN-15X, Fiber Choledochonephroscope

- Pathway: 510(k) (Traditional)
- Applicant: Pentax Precision Instrument Corp.
- Decided: May 30, 1995 after 75 days
- Product code: FBN (Choledochoscope And Accessories, Flexible/Rigid)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
104 later devices descend from it; 1 cites it directly.
1 of 105 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## 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
- 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

## Recalls of this device
- Apr 6, 2016 · Class II · Z-2066-2016: Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clips, stents, balloons, etc.) can become lodged in an endoscope's instrument channel.

Source page: https://510kreport.com/device/K951191
Methodology: https://510kreport.com/methodology