# K172298: Olympus Urf-P6/P6R

- Pathway: 510(k) (Traditional)
- Applicant: Olympus Medical Systems Corp.
- Decided: Mar 29, 2018 after 241 days
- Product code: FGB (Ureteroscope And Accessories, Flexible/Rigid)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K912120 (1991). 1 ancestor in all.
2 later devices descend from it; 1 cites it directly.
1 of 4 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K912120: Urf-P2 Ureterorenofiberscope/Choledochofiberscope, Olympus Corp. (1991) 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-0347-2024: 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
- Apr 20, 2022 · Class II · Z-1263-2022: Incorrect adhesive used to secure the diopter ring and nameplate ring. Improperly connected diopter ring may result in the loss of adjustment function leading to a blurred field of vision and unintent
- Apr 20, 2022 · Class II · Z-1264-2022: Incorrect adhesive used to secure the diopter ring and nameplate ring. Improperly connected diopter ring may result in the loss of adjustment function leading to a blurred field of vision and unintent
- Jan 17, 2018 · Class II · Z-2519-2018: Breakage of the endoscope's insertion tube bending section during surgical procedures.
- Jan 17, 2018 · Class II · Z-2520-2018: 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 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/K172298
Methodology: https://510kreport.com/methodology