# K912120: Urf-P2 Ureterorenofiberscope/Choledochofiberscope

- Pathway: 510(k) (Traditional)
- Applicant: Olympus Corp.
- Decided: Aug 7, 1991 after 85 days
- Product code: FBN (Choledochoscope And Accessories, Flexible/Rigid)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: 2 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
273 later devices descend from it; 4 cite it directly.
6 of 274 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K021074: Visera Cystovideoscope Olympus Cyf Type V/VA (2002), 268 descendants of its own
- K062049: Evis Exera II 180 System (2006), 158 descendants of its own
- K100584: Evis Exeraii 180 System (2010), 132 descendants of its own
- 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

## Recalls of this device
- Dec 18, 2024 · Class I · Z-0905-2025: Potential for inadvertent retention of biomaterial when the reprocessing procedure is not performed as instructed, so as not completely removing and disassembling the device.
- Dec 12, 2016 · Class II · Z-1251-2017: Olympus is recalling the URF-P6/P6R endoscopes due to a similar device (URF-V2/V2R endoscopes) but not identical, where adverse event complaints associated with tissue trauma, perforation and insertio

Source page: https://510kreport.com/device/K912120
Methodology: https://510kreport.com/methodology