# K172246: Olympus Urf-V2/V2R

- Pathway: 510(k) (Traditional)
- Applicant: Olympus Medical Systems Corp.
- Decided: Mar 30, 2018 after 247 days
- Product code: FGB (Ureteroscope And Accessories, Flexible/Rigid)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K853585 (1986). 8 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072957: Evis Exera II 180 System, Olympus Medical Systems Corporation (2008) Summary page 5.

## Most influential descendants
- K181451: Uretero-Reno Videoscope Olympus Urf-V3/V3R, Uretero-Reno Fiberscope Olympus Urf-P7/P7R (2019), 1 descendant of its own
- K191078: BAROnova Access Sheath Kit (2019), 0 descendants of its own

## Recalls of this device
- Sep 25, 2023 · Class II · Z-0348-2024: Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the poten
- Mar 25, 2022 · Class II · Z-1116-2022: The bending section of the URF-V2 may crack, resulting in an abnormal shape or abnormal angulation of the bending section.
- Jan 17, 2018 · Class II · Z-2518-2018: Potential breakage of the endoscope s insertion tube bending section during surgical procedures

## Indications for use
This instrument has been designed to be used with an Olympus video system center, light source, documentation equipment, monitor, EndoTherapy accessories, and other ancillary equipment for endoscopic diagnosis and treatment within the ureter and kidney.

Source page: https://510kreport.com/device/K172246
Methodology: https://510kreport.com/methodology