510(k) · Cleared

Recalled · Class II · 2023

Olympus Urf-P6/P6R

K172298510(k) TraditionalCleared Mar 29, 2018241-day reviewClass II21 CFR 876.1500Recalls 5

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Olympus Medical Systems Corp. · FGB Ureteroscope And Accessories, Flexible/Rigid

Cleared on Mar 29, 2018 as substantially equivalent to K912120 (Olympus Corp., 1991) after a 241-day review. Its family tree reaches back 1 generation to 1991. 1 of the 4 devices in its family, counting itself, has a Class I recall. 2 later devices descend from it. It has been recalled 5 times.

Decided: Mar 29, 2018
Review: 241 days
Class: Class II
Product code: FGB
Recalls: 5
Predicates: 1

Its longest line of descent runs back 1 generation to K912120 (1991). 2 later devices descend from it, 1 citing it directly. 1 of the 4 devices in this family, counting this one, has a Class I recall.

By dateBy generation

Root · 1 generation backK912120 Urf-P2 Ureterorenofiberscope/CholedochofiberscopeOlympus Corp. · 1991 · Recalled (Class I)
This deviceK172298 Olympus Urf-P6/P6ROlympus Medical Systems Corp. · 2018
Descendant · cites it directly · 1 of its ownK181451 Uretero-Reno Videoscope Olympus Urf-V3/V3R, Uretero-Reno Fiberscope…Olympus Medical Systems Corp. · 2019 · Recalled
Descendant · 2 generations on · 0 of its ownK191078 BAROnova Access Sheath KitBaronova, Inc. · 2019

Class I recalls in this family

K912120 Urf-P2 Ureterorenofiberscope/Choledochofiberscopedirect predicate · 1991

Most influential descendants

Showing 2 of 2 · See all

K181451Uretero-Reno Videoscope Olympus Urf-V3/V3R, Uretero-Reno Fiberscope Olympus Urf-P7/P7ROlympus Medical Systems Corp. · 2019 · cites it directly1descendant
K191078BAROnova Access Sheath KitBaronova, Inc. · 2019 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K912120	Urf-P2 Ureterorenofiberscope/Choledochofiberscope	Olympus Corp.	1991	Class I
0 (this device)	K172298	Olympus Urf-P6/P6R	Olympus Medical Systems Corp.	2018	—
+1	K181451	Uretero-Reno Videoscope Olympus Urf-V3/V3R, Uretero-Reno Fiberscope Olympus…	Olympus Medical Systems Corp.	2019	1
+2	K191078	BAROnova Access Sheath Kit	Baronova, Inc.	2019	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2019	2	0

FIG. 1 — Lineage of K172298, 1991–2019Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

1 device in this family has a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new FGB device

#1 K251951 Single-Use Video Flexible Ureterorenoscope…score 16.2 · 10 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K912120	Urf-P2 Ureterorenofiberscope/Choledochofiberscope Summary page 5 …Traditional 510(k) URETERO-RENO FIBERSCOPE OLYMPUS URF-P6/P6R 3. Predicate Device K912120 URETERORENOSCOPE OLYMPUS URF TYPE P2 4. Device Description This endoscope is composed from eyepiece section, control section an…	Olympus Corp.	1991	Class I

Also cleared against K912120: 3 other devices →

What descends from it? (2)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K181451	Uretero-Reno Videoscope Olympus Urf-V3/V3R, Uretero-Reno Fiberscope Olympus Urf-P7/P7R	Olympus Medical Systems Corp.	2019	1

Has anything in its family been recalled? (1 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Sep 25, 2023	Class II	Z-0347-2024	Under Investigation by firm	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 potential for contamination that could lead…
Apr 20, 2022	Class II	Z-1263-2022	Nonconforming Material/Component	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 unintentional contact with the patients body…
Apr 20, 2022	Class II	Z-1264-2022	Nonconforming Material/Component	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 unintentional contact with the patients body…
Jan 17, 2018	Class II	Z-2519-2018	Device Design	Breakage of the endoscope's insertion tube bending section during surgical procedures.
Jan 17, 2018	Class II	Z-2520-2018	Device Design	Breakage of the endoscope's insertion tube bending section during surgical procedures.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

K912120Urf-P2 Ureterorenofiberscope/CholedochofiberscopeOlympus Corp. · 1991 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall

What does this lineage say?

Its one ancestor has a recall, Class I.
Of its descendants, K181451 (Olympus Medical Systems Corp., 2019) has gone furthest, with 1 descendant of its own.
3 other devices also cite its predicate K912120.

How does its category compare?

All FGB devices

FGB Ureteroscope And Accessories, Flexible/Rigid: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.

FDA decisions per year · FGB

17in 2025

2007high 17 (2025) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FGB

134in 2025

2007high 217 (2024) · low 134 (2025)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · FGB

15in 2024

2007high 15 (2024) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · FGB

1,307in 2025

2007high 1,307 (2025) · low 4 (2009)2025

MAUDE reports naming product code FGB, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	0	—	0	6
2008	0	—	0	7
2009	0	—	0	4
2010	0	—	0	20
2011	0	—	0	17
2012	2	—	0	11
2013	1	—	0	8
2014	2	—	0	12
2015	1	—	0	16
2016	0	—	0	35
2017	2	—	0	142
2018	4	191	0	118
2019	2	—	0	207
2020	2	—	0	402
2021	3	191	0	325
2022	5	205	4	455
2023	8	183	1	458
2024	16	217	15	572
2025	17	134	0	1,307
2026	9	140	1	—

What is it indicated for?

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).

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K172298 · printed Nov 5, 2026

Cite this page

510(k) Report. “K172298: Olympus Urf-P6/P6R.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K172298

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026