510(k) · Cleared
ClearedWiScope OM Endoscope System, WiScope Single-Use Digital Flexible Ureteroscope.Choledochoscope, WiScope Image System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
OTU Medical, Inc. · FGB Ureteroscope And Accessories, Flexible/Rigid
Cleared on Jul 22, 2021 as substantially equivalent to K181977 (OTU Medical, Inc., 2018) and 1 other predicate after a 146-day review. Its family tree reaches back 10 generations to 1993. 1 of the 28 devices in its family, counting itself, has a Class I recall. 1 later device descends from it.
- Decided
- Jul 22, 2021
- Review
- 146 days
- Class
- Class II
- Product code
- FGB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 10 generations to K931154 (1993). 26 ancestors in all, the oldest K843084 (1985). 1 later device descends from it, 1 citing it directly. 1 of the 28 devices in this family, counting this one, has a Class I recall.
- Root · 10 generations backK931154 Evis 200 SystemOlympus Corp. · 1993
- 6 generations between
- 3 generations backK131369 Flexible Video-Uretero-Renoscope SystemKARL STORZ Endoscopy-America, Inc. · 2013 · Recalled
- 2 generations backK171076 Medical Video Endoscope SystemZhuhai Pusen Medical Technology Co., Ltd. · 2017
- 1 generation backK181977 WiScope Digital Endoscope SystemOTU Medical, Inc. · 2018
- This deviceK210579 WiScope OM Endoscope System, WiScope Single-Use Digital Flexible…OTU Medical, Inc. · 2021
- Descendant · cites it directly · 0 of its ownK231497 Choledochoscope SystemShenzhen HugeMed Medical Technical Development Co., Ltd. · 2024
Show all 10 generations
- Root · 10 generations backK931154 Evis 200 SystemOlympus Corp. · 1993
- 9 generations backK963033 BF 240/P240/IT240 Bronchovideoscope & AccessoriesOlympus America, Inc. · 1996 · Recalled
- 8 generations backK981543 Olympus LF-TP and LF-DP Tracheal Intubation Fiberscopes, Accessories…The Olympus Optical Co. · 1998 · Recalled
- 7 generations backK021074 Visera Cystovideoscope Olympus Cyf Type V/VAOlympus America, Inc. · 2002
- 6 generations backK030960 Ecn Electronic Video CystonephroscopeAcmi Corporation · 2003
- 5 generations backK042225 Acmi Invisio Icn, Models Icn-0564 and Icn-0565Acmi Corporation · 2004
- 4 generations backK060269 Acmi Dur-Digital Ureteroscope and Choledochoscope SystemAcmi Corporation · 2006
- 3 generations backK131369 Flexible Video-Uretero-Renoscope SystemKARL STORZ Endoscopy-America, Inc. · 2013 · Recalled
- 2 generations backK171076 Medical Video Endoscope SystemZhuhai Pusen Medical Technology Co., Ltd. · 2017
- 1 generation backK181977 WiScope Digital Endoscope SystemOTU Medical, Inc. · 2018
- This deviceK210579 WiScope OM Endoscope System, WiScope Single-Use Digital Flexible…OTU Medical, Inc. · 2021
Class I recalls in this family
- K912120 Urf-P2 Ureterorenofiberscope/Choledochofiberscope5 generations back · 1991
Most influential descendants
Showing 1 of 1 · See all- K231497Choledochoscope SystemShenzhen HugeMed Medical Technical Development Co., Ltd. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K931154 | Evis 200 System | Olympus Corp. | 1993 | — |
| −9 | K963033 | BF 240/P240/IT240 Bronchovideoscope & Accessories | Olympus America, Inc. | 1996 | 6 |
| −8 | K981543 | Olympus LF-TP and LF-DP Tracheal Intubation Fiberscopes, Accessories and… | The Olympus Optical Co. | 1998 | 5 |
| −7 | K021074 | Visera Cystovideoscope Olympus Cyf Type V/VA | Olympus America, Inc. | 2002 | — |
| −6 | K030960 | Ecn Electronic Video Cystonephroscope | Acmi Corporation | 2003 | — |
| −5 | K042225 | Acmi Invisio Icn, Models Icn-0564 and Icn-0565 | Acmi Corporation | 2004 | — |
| −4 | K060269 | Acmi Dur-Digital Ureteroscope and Choledochoscope System | Acmi Corporation | 2006 | — |
| −3 | K131369 | Flexible Video-Uretero-Renoscope System | KARL STORZ Endoscopy-America, Inc. | 2013 | 1 |
| −2 | K171076 | Medical Video Endoscope System | Zhuhai Pusen Medical Technology Co., Ltd. | 2017 | — |
| −1 | K181977 | WiScope Digital Endoscope System | OTU Medical, Inc. | 2018 | — |
| 0 (this device) | K210579 | WiScope OM Endoscope System, WiScope Single-Use Digital Flexible… | OTU Medical, Inc. | 2021 | — |
| +1 | K231497 | Choledochoscope System | Shenzhen HugeMed Medical Technical Development Co., Ltd. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 2 | 0 |
| 1991 | 2 | 1 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 2 | 0 |
| 1997 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 4 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 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.
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
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K181977 | WiScope Digital Endoscope SystemSummary page 4…predicate devices: Applicant Device name 510(k) Number Product code OTU Medical Inc. WiScope™ Digital Endoscope System K181977 FGB ACMI Corporation ACMI® DUR-Digital Ureteroscope and K060269 FBN, FGB… | 2018 |
| * | K060269 | Acmi Dur-Digital Ureteroscope and Choledochoscope SystemSummary page 4…510(k) Number Product code OTU Medical Inc. WiScope™ Digital Endoscope System K181977 FGB ACMI Corporation ACMI® DUR-Digital Ureteroscope and K060269 FBN, FGB Choledochoscope System (DUR®-D) 6. Device Description WiScope® OM Endosc… | 2006 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K231497 | Choledochoscope System | 2024 | 0 |
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
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 · 5 generations back · ◆ in the 1991 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 28 years and passes through 7 companies; a new generation was cleared every 2.9 years on median.
- 8 of the 26 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K231497 (Shenzhen HugeMed Medical Technical Development Co., Ltd., 2024) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K181977.
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. 2021, 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?
WiScope® OM Endoscope System is intended to be used by physicians to access, visualize, and perform procedures in the urinary tract and the kidney.
WiScope® OM Endoscope System is also intended to be used by physicians through percutaneous insertion to access, visualize, and perform procedures in the pancreaticobiliary system including the hepatic ducts and the common bile duct.
The instrument enables delivery and use of accessories such as biopsy forceps, laser fibers, graspers and retrieval baskets at a surgical site.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K210579 · printed Nov 6, 2026
Cite this page
510(k) Report. “K210579: WiScope OM Endoscope System, WiScope Single-Use Digital Flexible Ureteroscope.Choledochoscope, WiScope Image System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K210579
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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