510(k) · Cleared
ClearedSphincterotome
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hangzhou AGS MedTech Co., Ltd. · KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Cleared on Feb 5, 2021 as substantially equivalent to K172665 (Wilson-Cook Medical Inc./Cook Endoscopy, 2018) and 1 other predicate after a 284-day review. Its family tree reaches back 2 generations to 1997. 2 later devices descend from it.
- Decided
- Feb 5, 2021
- Review
- 284 days
- Class
- Class II
- Product code
- KNS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K972674 (1997). 4 ancestors in all, the oldest K901443 (1990). 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK972674 Wilson-Cook Needle Knife PapillotomeWilson-Cook Medical, Inc. · 1997
- 1 generation backK040981 Usw Needleknife PapillotomeWilson-Cook Medical, Inc. · 2004
- This deviceK201121 SphincterotomeHangzhou AGS MedTech Co., Ltd. · 2021
- Descendant · cites it directly · 0 of its ownK232476 Disposable SphincterotomeZhejiang Soudon Medical Technology Co., Ltd. · 2023
- Descendant · cites it directly · 0 of its ownK222421 SphincterotomeHangzhou AGS MedTech Co., Ltd. · 2023
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K972674 | Wilson-Cook Needle Knife Papillotome | Wilson-Cook Medical, Inc. | 1997 | — |
| −1 | K040981 | Usw Needleknife Papillotome | Wilson-Cook Medical, Inc. | 2004 | — |
| 0 (this device) | K201121 | Sphincterotome | Hangzhou AGS MedTech Co., Ltd. | 2021 | — |
| +1 | K232476 | Disposable Sphincterotome | Zhejiang Soudon Medical Technology Co., Ltd. | 2023 | — |
| +1 | K222421 | Sphincterotome | Hangzhou AGS MedTech Co., Ltd. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 2018 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 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 |
|---|---|---|---|
| * | K172665 | Classic Cotton Cannulatome®, CannulaTome II® Double Lumen Sphincterotome, Cotton…Summary page 5…Howell D.A.S.H.® Device Name: Sphincterotome with DomeTip Common Name: Sphincterotome with DomeTip 510(k) Number: K172665 Regulation class: Class II Regulation Number: 876.4300 Regulation Description: Endoscopic electrosurgical uni… | 2018 |
| * | K040981 | Usw Needleknife PapillotomeSummary page 6…2 of 11 Trade Name: Huibregtse® Device Name: Needle knife Common Name: Needle knife 510(k) Number: K040981 Regulation class: Class II Regulation Number: 876.4300 Regulation Description: Endoscopic electrosur… | 2004 |
What descends from it? (2)
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 24 years and passes through 2 companies; a new generation was cleared every 16.8 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K232476 (Zhejiang Soudon Medical Technology Co., Ltd., 2023) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K172665.
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. 2021, 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?
The Sphincterotome is indicated for use in the cannulation of the biliary ducts and the transendoscopic sphincterotomy of the Papilla of Yater and/or the Spincter of Oddi. The device is supplied sterile and intended for single use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K201121 · printed Nov 6, 2026
Cite this page
510(k) Report. “K201121: Sphincterotome.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K201121
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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