510(k) · Cleared
ClearedWilson-Cook Tri-Tome Select Plus
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wilson-Cook Medical, Inc. · KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Cleared on Dec 19, 2003 as substantially equivalent to K901443 (Wilson-Cook Medical, Inc., 1990) and 1 other predicate after a 78-day review. Its family tree reaches back 2 generations to 1997. 6 later devices descend from it.
- Decided
- Dec 19, 2003
- Review
- 78 days
- Class
- Class II
- Product code
- KNS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K970053 (1997). 3 ancestors in all, the oldest K901443 (1990). 6 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK970053 UltratomerxBoston Scientific Corp · 1997
- 1 generation backK013153 Autotome RX Model # 4515, 4516Boston Scientific Corp · 2001 · Recalled
- This deviceK033203 Wilson-Cook Tri-Tome Select PlusWilson-Cook Medical, Inc. · 2003
- Descendant · cites it directly · 4 of its ownK052051 Omni SphincterotomeWilson-Cook Medical, Inc. · 2005 · Recalled
- Descendant · 2 generations on · 3 of its ownK172288 Fusion OMNI SphincterotomeWilson-Cook Medical Inc./Cook Endoscopy · 2018
- Descendant · 3 generations on · 1 of its ownK192339 TeslaTome Bipolar Sphincterotome, Tesla Bipolar Active CordWilson-Cook Medical, Inc. · 2020
- Descendant · 3 generations on · 0 of its ownK251104 SureTome™ SW Sphincterotome with DomeTipWilson-Cook Medical · 2025
- Descendant · 4 generations on · 0 of its ownK243568 Teslatome Bipolar Sphincterotome; Tesla BiCord Active CordWilson-Cook Medical, Inc. · 2025 · Recalled
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K052051Omni SphincterotomeWilson-Cook Medical, Inc. · 2005 · cites it directly4descendants
- K172288Fusion OMNI SphincterotomeWilson-Cook Medical Inc./Cook Endoscopy · 2018 · 2 generations on3descendants
- K192339TeslaTome Bipolar Sphincterotome, Tesla Bipolar Active CordWilson-Cook Medical, Inc. · 2020 · 3 generations on1descendant
- K251104SureTome™ SW Sphincterotome with DomeTipWilson-Cook Medical · 2025 · 3 generations on0descendants
- K243568Teslatome Bipolar Sphincterotome; Tesla BiCord Active CordWilson-Cook Medical, Inc. · 2025 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K970053 | Ultratomerx | Boston Scientific Corp | 1997 | — |
| −1 | K013153 | Autotome RX Model # 4515, 4516 | Boston Scientific Corp | 2001 | 32 |
| 0 (this device) | K033203 | Wilson-Cook Tri-Tome Select Plus | Wilson-Cook Medical, Inc. | 2003 | — |
| +1 | K052051 | Omni Sphincterotome | Wilson-Cook Medical, Inc. | 2005 | 2 |
| +2 | K172288 | Fusion OMNI Sphincterotome | Wilson-Cook Medical Inc./Cook Endoscopy | 2018 | — |
| +3 | K192339 | TeslaTome Bipolar Sphincterotome, Tesla Bipolar Active Cord | Wilson-Cook Medical, Inc. | 2020 | — |
| +3 | K251104 | SureTome™ SW Sphincterotome with DomeTip | Wilson-Cook Medical | 2025 | — |
| +4 | 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 |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2018 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K901443 | Zimmon PapillotomeSummary page 1…21 CFR § 876.4300 PREDICATE DEVICES: Wilson-Cook Sphincterotome/Papillotome (k901 443) Microvasive AutotomeTm RX (k013153) INTENDED USE: Wilson-C… | 1990 |
| * | K013153 | Autotome RX Model # 4515, 4516Summary page 1…Wilson-Cook Sphincterotome/Papillotome (k901 443) Microvasive AutotomeTm RX (k013153) INTENDED USE: Wilson-Cook's Tri-Tome Select Plus Sphincter… | 2001 |
What descends from it? (6)
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 6 years and passes through 2 companies; a new generation was cleared every 4.6 years on median.
- 2 of the 3 ancestors have a recall of any class.
- Of its descendants, K052051 (Wilson-Cook Medical, Inc., 2005) has gone furthest, with 4 descendants of its own.
- 1 other device also cites its predicate K901443.
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.
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?
Used for cannulation of the ductal system and for sphincterotomy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033203 · printed Nov 6, 2026
Cite this page
510(k) Report. “K033203: Wilson-Cook Tri-Tome Select Plus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033203
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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