510(k) · Cleared
ClearedClassic Cotton Cannulatome®, CannulaTome II® Double Lumen Sphincterotome, Cotton CannulaTome II® PC, UTS® Ultra Taper Sphincterotome, Tri-Tome pc® Triple Lumen Sphincterotome, Howell D.A.S.H.® Sphincterotome with DomeTip®, Billroth II Sphincterotome, Soehendra® BII Sphincterotome, Models ACU-1 and ACU-1-VL active cords
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 May 24, 2018 as substantially equivalent to K901443 (Wilson-Cook Medical, Inc., 1990) after a 261-day review. Its family tree reaches back 1 generation to 1990. 4 later devices descend from it.
- Decided
- May 24, 2018
- Review
- 261 days
- Class
- Class II
- Product code
- KNS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K901443 (1990). 4 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK901443 Zimmon PapillotomeWilson-Cook Medical, Inc. · 1990 · Recalled
- This deviceK172665 Classic Cotton Cannulatome®, CannulaTome II® Double Lumen…Wilson-Cook Medical Inc./Cook Endoscopy · 2018
- Descendant · cites it directly · 2 of its ownK201121 SphincterotomeHangzhou AGS MedTech Co., Ltd. · 2021
- Descendant · cites it directly · 0 of its ownK251104 SureTome™ SW Sphincterotome with DomeTipWilson-Cook Medical · 2025
- Descendant · 2 generations on · 0 of its ownK232476 Disposable SphincterotomeZhejiang Soudon Medical Technology Co., Ltd. · 2023
- Descendant · 2 generations on · 0 of its ownK222421 SphincterotomeHangzhou AGS MedTech Co., Ltd. · 2023
Most influential descendants
Showing 4 of 4 · See all- K201121SphincterotomeHangzhou AGS MedTech Co., Ltd. · 2021 · cites it directly2descendants
- K251104SureTome™ SW Sphincterotome with DomeTipWilson-Cook Medical · 2025 · cites it directly0descendants
- K232476Disposable SphincterotomeZhejiang Soudon Medical Technology Co., Ltd. · 2023 · 2 generations on0descendants
- K222421SphincterotomeHangzhou AGS MedTech Co., Ltd. · 2023 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K901443 | Zimmon Papillotome | Wilson-Cook Medical, Inc. | 1990 | 1 |
| 0 (this device) | K172665 | Classic Cotton Cannulatome®, CannulaTome II® Double Lumen Sphincterotome… | Wilson-Cook Medical Inc./Cook Endoscopy | 2018 | — |
| +1 | K201121 | Sphincterotome | Hangzhou AGS MedTech Co., Ltd. | 2021 | — |
| +1 | K251104 | SureTome™ SW Sphincterotome with DomeTip | Wilson-Cook Medical | 2025 | — |
| +2 | K232476 | Disposable Sphincterotome | Zhejiang Soudon Medical Technology Co., Ltd. | 2023 | — |
| +2 | K222421 | Sphincterotome | Hangzhou AGS MedTech Co., Ltd. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2023 | 2 | 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 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 |
|---|---|---|---|
| * | K901443 | Zimmon PapillotomeSummary page 4…KNS Device Class: Class II Review Panel: Gastroenterology-Urology Predicate Device Name: Zimmon® Papillotome 510(k) Number: K901443 Date: Cleared June 18, 1990 Device Description The sphincterotomes described in this submission are a sterile,… | 1990 |
What descends from it? (4)
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?
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?
Howell D.A.S.H.® Sphincterotome with DomeTip® (Cook Reference Part Numbers DASH-21, DASH-21-480, DASH-1, DASH-260, DASH-480, DASH-ACRO-25-450, DASH-35, DASH-ACRO-35-260, DASH-35-480, DASH-ACRO-35-450): This device is used for cannulation of the ductal system and for sphincterotomy. If preloaded, also aids in bridging difficult strictures during ERCP. Tri-Tome pc® Triple Lumen Sphincterotome (Cook Reference Part Numbers TRI-20, TRI-20M, TRI-25, TRI-25M…
Read the full statement (189 words)
Howell D.A.S.H.® Sphincterotome with DomeTip® (Cook Reference Part Numbers DASH-21, DASH-21-480, DASH-1, DASH-260, DASH-480, DASH-ACRO-25-450, DASH-35, DASH-ACRO-35-260, DASH-35-480, DASH-ACRO-35-450): This device is used for cannulation of the ductal system and for sphincterotomy. If preloaded, also aids in bridging difficult strictures during ERCP.
Tri-Tome pc® Triple Lumen Sphincterotome (Cook Reference Part Numbers TRI-20, TRI-20M, TRI-25, TRI-25M, TRI-25M-P, TRI-25M-SLT, TRI-30, TRI-30M): This device is used for cannulation of the ductal system and for sphincterotomy.
Classic Cotton® CannulaTome® (Cook Reference Part Numbers CCPT-25, CCPT-25-MONO, CCPT-25ME), CannulaTome II® Double Lumen Sphincterotome (Cook Reference Part Numbers CT-20, CT-20M, CT-30, CT-30M), Cotton Cannulatome II® PreCurved Double Lumen Sphincterotome (Cook Reference Part Numbers CT-25, CT-25M, CT-25M-P UTS®), and Ultra Taper Sphincterotome (Cook Reference Part Numbers UTS-15, UTS-20, UTS-20M, UTS-25, UTS-25M, UTS-30, UTS-30M): This device is used for cannulation of the ductal system and for sphincterotomy.
Billroth II Sphincterotome (Cook Reference Part Numbers PTG-20-6-BII-NG) and Soehendra® BII Sphincterotome (Cook Reference Part Numbers PT-5.5-BII-SOEHENDRA): This device is used for the cannulation of the ductal system and for sphincterotomy.
Models ACU-1 and ACU-1-VL active cords: This device is used to connect Cook monopolar electrosurgical accessories to compatible electrosurgical generators.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K172665 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172665: Classic Cotton Cannulatome®, CannulaTome II® Double Lumen Sphincterotome, Cotton CannulaTome II® PC, UTS® Ultra Taper Sphincterotome, Tri-Tome pc® Triple Lumen Sphincterotome, Howell D.A.S.H.® Sphincterotome with DomeTip®, Billroth II Sphincterotome, Soehendra® BII Sphincterotome, Models ACU-1 and ACU-1-VL active cords.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172665
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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