510(k) · Cleared
ClearedFlexible Video-Choledochoscope System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shanghai SeeGen Photoelectric Technology Co., Ltd. · FBN Choledochoscope And Accessories, Flexible/Rigid
Cleared on Apr 20, 2023 after a 266-day review. The summary cites 2 numbers, none of which could be confirmed as its predicate (see the table below). 1 later device descends from it.
- Decided
- Apr 20, 2023
- Review
- 266 days
- Class
- Class II
- Product code
- FBN
- Recalls
- None
- Predicates
- 2
1 later device descends from it, 1 citing it directly.
- This deviceK222261 Flexible Video-Choledochoscope SystemShanghai SeeGen Photoelectric Technology Co., Ltd. · 2023
- Descendant · cites it directly · 0 of its ownK243535 Flexible Video-Choledochoscope (CHV-110J-U); Flexible…Shanghai SeeGen Photoelectric Technology Co., Ltd. · 2025
Most influential descendants
Showing 1 of 1 · See all- K243535Flexible Video-Choledochoscope (CHV-110J-U); Flexible Video-Choledochoscope (CHV-US120J-U)Shanghai SeeGen Photoelectric Technology Co., Ltd. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K222261 | Flexible Video-Choledochoscope System | Shanghai SeeGen Photoelectric Technology Co., Ltd. | 2023 | — |
| +1 | K243535 | Flexible Video-Choledochoscope (CHV-110J-U); Flexible Video-Choledochoscope… | Shanghai SeeGen Photoelectric Technology Co., Ltd. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 FBN? 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 FBN device
- #1 K254153 Single-use Video Scope; PB Digital Controllerscore 14.4 · 12 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K182799 | FDA’s K182799 is Arthrex Univers II Shoulder Prosthesis System: Titanium Humeral Heads Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2019 |
| Kept off the family tree | K182899 | SpyGlass DS II Access and Delivery Catheter Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree |
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 |
|---|---|---|---|
| K243535 | Flexible Video-Choledochoscope (CHV-110J-U); Flexible Video-Choledochoscope (CHV-US120J-U) | 2025 | 0 |
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?
- Of its descendants, K243535 (Shanghai SeeGen Photoelectric Technology Co., Ltd., 2025) has gone furthest, with 0 descendants of its own.
How does its category compare?
All FBN devicesFBN Choledochoscope And Accessories, Flexible/Rigid: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · FBN
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FBN
150in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FBN
1in 2024
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · FBN
118in 2025
MAUDE reports naming product code FBN, 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 | 1 |
| 2008 | 3 | 64 | 0 | 5 |
| 2009 | 0 | — | 0 | 4 |
| 2010 | 1 | — | 0 | 2 |
| 2011 | 0 | — | 0 | 2 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 2 |
| 2014 | 0 | — | 0 | 2 |
| 2015 | 1 | — | 0 | 2 |
| 2016 | 1 | — | 0 | 168 |
| 2017 | 0 | — | 0 | 224 |
| 2018 | 1 | — | 0 | 639 |
| 2019 | 1 | — | 0 | 105 |
| 2020 | 1 | — | 1 | 173 |
| 2021 | 0 | — | 0 | 158 |
| 2022 | 0 | — | 0 | 283 |
| 2023 | 4 | 215 | 1 | 105 |
| 2024 | 2 | — | 1 (1) | 107 |
| 2025 | 3 | 150 | 0 | 118 |
| 2026 | 3 | 175 | 1 | — |
What is it indicated for?
The Flexible Video-Choledochoscope System is indicated for use in diagnostic and therapeutic applications during endoscopic procedures in the pancreatico-biliary system including the hepatic ducts. The Flexible Video-Choledochoscope System comprises two components: the Flexible Video-Choledochoscope and Imaging Processor System (Including Light Source). The Flexible Video-Choledochoscope is indicated for use in diagnostic and therapeutic applications…
Read the full statement (101 words)
The Flexible Video-Choledochoscope System is indicated for use in diagnostic and therapeutic applications during endoscopic procedures in the pancreatico-biliary system including the hepatic ducts.
The Flexible Video-Choledochoscope System comprises two components: the Flexible Video-Choledochoscope and Imaging Processor System (Including Light Source).
The Flexible Video-Choledochoscope is indicated for use in diagnostic and therapeutic applications during endoscopic procedures in the pancreatico-biliary system including the hepatic ducts.
The imaging processor system (including the light source) provides illumination for Flexible Video-Choledochoscope and is also used to receive the signal from the endoscope, then convert it into an image and display it on the examination monitor.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K222261 · printed Nov 6, 2026
Cite this page
510(k) Report. “K222261: Flexible Video-Choledochoscope System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K222261
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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