510(k) · Cleared
ClearedPolyscope Flexible Endoscopy Catheter; 10,000 Pixel Fiber Optic; Xenon Light Source, Model LS-200
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lumenis, Inc. · ODF Mini Endoscope, Gastroenterology-Urology
Cleared on Sep 30, 2009 as substantially equivalent to K050403 (Boston Scientific Corp, 2005) and 2 other predicates after a 91-day review. Its family tree reaches back 4 generations to 1986. 11 later devices descend from it.
- Decided
- Sep 30, 2009
- Review
- 91 days
- Class
- Class II
- Product code
- ODF
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K853585 (1986). 10 ancestors in all. 11 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 deviceK091962 Polyscope Flexible Endoscopy Catheter; 10,000 Pixel Fiber Optic…Lumenis, Inc. · 2009
- Descendant · cites it directly · 10 of its ownK132389 Cellvizio 100 Series System and Cellvizio System with Confocal…Daniel & Daniel Consulting · 2014
- Descendant · 2 generations on · 9 of its ownK141358 Cellvizio 100 Series with System Confocal MiniprobesMauna Kea Technologies · 2014
- Descendant · 3 generations on · 7 of its ownK160416 CystoFlex UHD R-C, CelioFlex UHD 5-C, Cellvizio 100 Series (800)…Mauna Kea Technologies · 2016
- Descendant · 2 generations on · 7 of its ownK150831 Cellvizio 100 Series System with Confocal MiniprobesMauna Kea Technologies · 2015
- Descendant · 3 generations on · 6 of its ownK172844 Cellvizio 100 Series System with Confocal MiniprobesMauna Kea Technologies · 2017
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K132389Cellvizio 100 Series System and Cellvizio System with Confocal Miniprobes; Uroflex B and…Daniel & Daniel Consulting · 2014 · cites it directly10descendants
- K141358Cellvizio 100 Series with System Confocal MiniprobesMauna Kea Technologies · 2014 · 2 generations on9descendants
- K160416CystoFlex UHD R-C, CelioFlex UHD 5-C, Cellvizio 100 Series (800) with Confocal MiniprobesMauna Kea Technologies · 2016 · 3 generations on7descendants
- K150831Cellvizio 100 Series System with Confocal MiniprobesMauna Kea Technologies · 2015 · 2 generations on7descendants
- K172844Cellvizio 100 Series System with Confocal MiniprobesMauna Kea Technologies · 2017 · 3 generations on6descendants
View 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) | K091962 | Polyscope Flexible Endoscopy Catheter; 10,000 Pixel Fiber Optic; Xenon Light… | Lumenis, Inc. | 2009 | — |
| +1 | K132389 | Cellvizio 100 Series System and Cellvizio System with Confocal Miniprobes… | Daniel & Daniel Consulting | 2014 | — |
| +2 | K141358 | Cellvizio 100 Series with System Confocal Miniprobes | Mauna Kea Technologies | 2014 | — |
| +3 | K160416 | CystoFlex UHD R-C, CelioFlex UHD 5-C, Cellvizio 100 Series (800) with Confocal… | Mauna Kea Technologies | 2016 | — |
| +2 | K150831 | Cellvizio 100 Series System with Confocal Miniprobes | Mauna Kea Technologies | 2015 | — |
| +3 | K172844 | Cellvizio 100 Series System with Confocal Miniprobes | Mauna Kea Technologies | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1997 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 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 ODF? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K050403 | Spyglass Direct Visulation ProbeSummary page 1…roenterology/Urology C. PREDICATE DEVICE: C. 1- PolyScope Flexible Endoscope 1. The Boston Scientific SpyGlass direct visualization probe (K050403). 2. The Olympus VISERA Uretero-Reno Videoscope, Olympus XURF type V - (K072957) C.2 - Poly… | 2005 |
| * | K072957 | Evis Exera II 180 SystemSummary page 1…1. The Boston Scientific SpyGlass direct visualization probe (K050403). 2. The Olympus VISERA Uretero-Reno Videoscope, Olympus XURF type V - (K072957) C.2 - PolyScope Xenon Light Source The Olympus EVIS EXERA Xenon Light Source CLV-160A (KO51645) === Page… | 2008 |
| * | K051645 | Evis Exera 160A SystemSummary page 2…072957). Also, the PolyScope Xenon Light Source has the same intended use, general design and same fundamental scientific technology as the predicate device (K051645). The PolyScope Flexible Endoscope and the PolyScope Xenon Light Source use a technology substantially equivalent to… | 2005 |
What descends from it? (11)
See all 111 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K132389 | Cellvizio 100 Series System and Cellvizio System with Confocal Miniprobes; Uroflex B and… | 2014 | 10 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 23 years and passes through 4 companies; a new generation was cleared every 9.5 years on median.
- 6 of the 10 ancestors have a recall of any class.
- Of its descendants, K132389 (Daniel & Daniel Consulting, 2014) has gone furthest, with 10 descendants of its own.
- 3 other devices also cite its predicate K050403.
How does its category compare?
All ODF devicesODF Mini Endoscope, Gastroenterology-Urology: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · ODF
1in 2010
2026 to Oct 25, outlined.
Median 510(k) review, days · ODF
Too few ODF 510(k)s in any year since 2007 to give a median.
Recalls per year · ODF
No recall names ODF since 2007.
Adverse event reports per year · ODF
1in 2022
MAUDE reports naming product code ODF, 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 | 0 |
| 2008 | 0 | — | 0 | 5 |
| 2009 | 2 | — | 0 | 4 |
| 2010 | 1 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 5 |
| 2012 | 0 | — | 0 | 4 |
| 2013 | 0 | — | 0 | 3 |
| 2014 | 0 | — | 0 | 2 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The PolyScope Flexible Endoscope is indicated in flexible endoscopic procedures for diagnostic and therapeutic applications where flexible endoscopes are standard of care including:
· Gastroenterology, including procedure of the Biliary system involving the hepatic and pancreatic ducts.
· Urology, including procedures involving the bladder, ureter, renal pelvis and kidney.
The PolyScope Xenon-Endoscopic light source LS 200 provides white examination light (sunlight spectrum) for all endoscopic applications including:
During video endoscopy.
During fiber endoscopy.
During micro-endoscopy.
During endoscopy using rigid optics.
During usage of forehead illumination.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091962 · printed Nov 5, 2026
Cite this page
510(k) Report. “K091962: Polyscope Flexible Endoscopy Catheter; 10,000 Pixel Fiber Optic; Xenon Light Source, Model LS-200.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K091962
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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