# K181451: Uretero-Reno Videoscope Olympus Urf-V3/V3R, Uretero-Reno Fiberscope Olympus Urf-P7/P7R

- Pathway: 510(k) (Traditional)
- Applicant: Olympus Medical Systems Corp.
- Decided: Jan 16, 2019 after 229 days
- Product code: FGB (Ureteroscope 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
Longest line of descent: 5 generations back to K853585 (1986). 11 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 13 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172246: Olympus Urf-V2/V2R, Olympus Medical Systems Corp. (2018) Summary page 5.
- K172298: Olympus Urf-P6/P6R, Olympus Medical Systems Corp. (2018) Summary page 5.

## Most influential descendants
- 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

## Indications for use
-OLYMPUS URF-V3/V3R 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. -OLYMPUS URF-P7/P7R This instrument has been designed to be used with an Olympus light source, documentation equipment, monitor, EndoTherapy accessories, and other ancillary equipment for endoscopic diagnosis and treatment within the ureter, kidney and biliary tract (common bile duct and hepatic duct).

Source page: https://510kreport.com/device/K181451
Methodology: https://510kreport.com/methodology