510(k) · Cleared
Recalled · Class II · 2023Olympus Urf-V2/V2R
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Olympus Medical Systems Corp. · FGB Ureteroscope And Accessories, Flexible/Rigid
Cleared on Mar 30, 2018 as substantially equivalent to K072957 (Olympus Medical Systems Corporation, 2008) after a 247-day review. Its family tree reaches back 4 generations to 1986. 2 later devices descend from it. It has been recalled 3 times.
- Decided
- Mar 30, 2018
- Review
- 247 days
- Class
- Class II
- Product code
- FGB
- Recalls
- 3
- Predicates
- 1
Its longest line of descent runs back 4 generations to K853585 (1986). 8 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK853585 Olympus Evs-Endoscopic Video Image & Data SysOlympus Corp. · 1986 · Recalled
- 3 generations backK954451 Evis 140 SystemOlympus America, Inc. · 1996 · Recalled
- 2 generations backK051645 Evis Exera 160A SystemOlympus Medical Systems Corporation · 2005 · Recalled
- 1 generation backK072957 Evis Exera II 180 SystemOlympus Medical Systems Corporation · 2008 · Recalled
- This deviceK172246 Olympus Urf-V2/V2ROlympus 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
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K853585 | Olympus Evs-Endoscopic Video Image & Data Sys | Olympus Corp. | 1986 | 2 |
| −3 | K954451 | Evis 140 System | Olympus America, Inc. | 1996 | 3 |
| −2 | K051645 | Evis Exera 160A System | Olympus Medical Systems Corporation | 2005 | 3 |
| −1 | K072957 | Evis Exera II 180 System | Olympus Medical Systems Corporation | 2008 | 1 |
| 0 (this device) | K172246 | Olympus Urf-V2/V2R | 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 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 2 | 0 |
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.
Planning a device in FGB? 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
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 | Decided |
|---|---|---|---|
| * | K072957 | Evis Exera II 180 SystemSummary page 5…Traditional 510(k) URETERO-RENO VIDEOSCOPE OLYMPUS URF-V2/V2R 3. Predicate Device K072957 VISERA URETERO-RENO VIDEOSCOPE OLYMPUS XURF TYPE V 4. Device Description This endoscope is composed from flexible insertion tube… | 2008 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K181451 | Uretero-Reno Videoscope Olympus Urf-V3/V3R, Uretero-Reno Fiberscope Olympus Urf-P7/P7R | 2019 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 25, 2023 | Class II | Z-0348-2024 | 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… |
| Mar 25, 2022 | Class II | Z-1116-2022 | Process change control | 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 | Device Design | Potential breakage of the endoscope s insertion tube bending section during surgical procedures |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 32 years and passes through 4 companies; a new generation was cleared every 10.0 years on median.
- 6 of the 8 ancestors have a recall of any class.
- 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 K072957.
How does its category compare?
All FGB devicesFGB 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
2026 to Oct 25, outlined.
Median 510(k) review, days · FGB
134in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FGB
15in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FGB
1,307in 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 video system center, light source, documentation equipment, monitor, EndoTherapy accessories, and other ancillary equipment for endoscopic diagnosis and treatment within the ureter and kidney.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K172246 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172246: Olympus Urf-V2/V2R.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172246
Report an extraction error
Are you the manufacturer?
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