510(k) · Cleared
ClearedFusion OMNI Sphincterotome
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wilson-Cook Medical Inc./Cook Endoscopy · KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Cleared on Apr 17, 2018 as substantially equivalent to K052051 (Wilson-Cook Medical, Inc., 2005) after a 260-day review. Its family tree reaches back 4 generations to 1997. 3 later devices descend from it.
- Decided
- Apr 17, 2018
- Review
- 260 days
- Class
- Class II
- Product code
- KNS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K970053 (1997). 5 ancestors in all, the oldest K901443 (1990). 3 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK970053 UltratomerxBoston Scientific Corp · 1997
- 3 generations backK013153 Autotome RX Model # 4515, 4516Boston Scientific Corp · 2001 · Recalled
- 2 generations backK033203 Wilson-Cook Tri-Tome Select PlusWilson-Cook Medical, Inc. · 2003
- 1 generation backK052051 Omni SphincterotomeWilson-Cook Medical, Inc. · 2005 · Recalled
- This deviceK172288 Fusion OMNI SphincterotomeWilson-Cook Medical Inc./Cook Endoscopy · 2018
- Descendant · cites it directly · 1 of its ownK192339 TeslaTome Bipolar Sphincterotome, Tesla Bipolar Active CordWilson-Cook Medical, Inc. · 2020
- Descendant · cites it directly · 0 of its ownK251104 SureTome™ SW Sphincterotome with DomeTipWilson-Cook Medical · 2025
- Descendant · 2 generations on · 0 of its ownK243568 Teslatome Bipolar Sphincterotome; Tesla BiCord Active CordWilson-Cook Medical, Inc. · 2025 · Recalled
Most influential descendants
Showing 3 of 3 · See all- K192339TeslaTome Bipolar Sphincterotome, Tesla Bipolar Active CordWilson-Cook Medical, Inc. · 2020 · cites it directly1descendant
- K251104SureTome™ SW Sphincterotome with DomeTipWilson-Cook Medical · 2025 · cites it directly0descendants
- K243568Teslatome Bipolar Sphincterotome; Tesla BiCord Active CordWilson-Cook Medical, Inc. · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K970053 | Ultratomerx | Boston Scientific Corp | 1997 | — |
| −3 | K013153 | Autotome RX Model # 4515, 4516 | Boston Scientific Corp | 2001 | 32 |
| −2 | K033203 | Wilson-Cook Tri-Tome Select Plus | Wilson-Cook Medical, Inc. | 2003 | — |
| −1 | K052051 | Omni Sphincterotome | Wilson-Cook Medical, Inc. | 2005 | 2 |
| 0 (this device) | K172288 | Fusion OMNI Sphincterotome | Wilson-Cook Medical Inc./Cook Endoscopy | 2018 | — |
| +1 | K192339 | TeslaTome Bipolar Sphincterotome, Tesla Bipolar Active Cord | Wilson-Cook Medical, Inc. | 2020 | — |
| +1 | K251104 | SureTome™ SW Sphincterotome with DomeTip | Wilson-Cook Medical | 2025 | — |
| +2 | K243568 | Teslatome Bipolar Sphincterotome; Tesla BiCord Active Cord | Wilson-Cook Medical, Inc. | 2025 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2025 | 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 KNS? 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 KNS device
- #1 K241271 Aqua Medical RF Vapor Ablation Systemscore 17.2 · 20 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 |
|---|---|---|---|
| * | K052051 | Omni SphincterotomeSummary page 4…Papillotome, sphincterotome Endoscopic electrosurgical unit and accessories 21 CFR 876.4300 KNS Class II Gastroenterology-Urology Wilson-Cook OMNI™ Sphincterotome K052051 Cleared June 18, 1990 This device is used for cannulation of the ductal system and for sphincterotomy. If preloaded, also aids i… | 2005 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 21 years and passes through 3 companies; a new generation was cleared every 4.6 years on median.
- 3 of the 5 ancestors have a recall of any class.
- Of its descendants, K192339 (Wilson-Cook Medical, Inc., 2020) has gone furthest, with 1 descendant of its own.
How does its category compare?
All KNS devicesKNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · KNS
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KNS
171in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KNS
14in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KNS
1,504in 2025
MAUDE reports naming product code KNS, 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 | 1 | — | 3 | 164 |
| 2008 | 3 | 61 | 5 | 587 |
| 2009 | 3 | 212 | 2 | 1,027 |
| 2010 | 4 | 168 | 0 | 908 |
| 2011 | 1 | — | 2 | 860 |
| 2012 | 2 | — | 0 | 848 |
| 2013 | 2 | — | 0 | 449 |
| 2014 | 1 | — | 0 | 405 |
| 2015 | 3 | 252 | 0 | 406 |
| 2016 | 3 | 30 | 6 | 457 |
| 2017 | 3 | 48 | 1 | 446 |
| 2018 | 5 | 62 | 0 | 563 |
| 2019 | 7 | 66 | 0 | 668 |
| 2020 | 4 | 212 | 0 | 906 |
| 2021 | 4 | 139 | 41 | 814 |
| 2022 | 3 | 182 | 0 | 913 |
| 2023 | 9 | 83 | 0 | 976 |
| 2024 | 3 | 198 | 14 | 1,533 |
| 2025 | 11 | 171 | 0 | 1,504 |
| 2026 | 2 | — | 4 | — |
What is it indicated for?
This device is used for cannulation of the ductal system and for sphincterotomy. If preloaded, also aids in bridging difficult strictures during ERCP.
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/K172288 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172288: Fusion OMNI Sphincterotome.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172288
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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