510(k) · Cleared
ClearedRotatable Snares
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Corporation · FDI Snare, Flexible
Cleared on Mar 30, 2016 as substantially equivalent to K131700 (Boston Scientific Corp, 2013) after a 23-day review. Its family tree reaches back 3 generations to 1995. 4 later devices descend from it.
- Decided
- Mar 30, 2016
- Review
- 23 days
- Class
- Class II
- Product code
- FDI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K950496 (1995). 5 ancestors in all, the oldest K941750 (1994). 4 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK950496 Snare, Flexible, Electrosurgical Cutting & Coagulation Device &…Boston Scientific Corp · 1995
- 2 generations backK992477 RotosnareInscope, LLC · 1999
- 1 generation backK131700 Sensation Short Throw, Captiflex, Captivator, Captivator II…Boston Scientific Corp · 2013 · Recalled
- This deviceK160637 Rotatable SnaresBoston Scientific Corporation · 2016
- Descendant · cites it directly · 3 of its ownK172758 Rotatable Snares, Non-Rotatable SnaresZhejiang Chuangxiang Medical Technology Co., Ltd. · 2018
- Descendant · 2 generations on · 1 of its ownK183289 ClearGrasp SnareFinemedix Co., Ltd. · 2019
- Descendant · 3 generations on · 0 of its ownK220846 Core-SnareIncore Co., Ltd. · 2022
- Descendant · 2 generations on · 0 of its ownK213222 Disposable Polypectomy SnareBeijing Zksk Technology Co., Ltd. · 2022
Most influential descendants
Showing 4 of 4 · See all- K172758Rotatable Snares, Non-Rotatable SnaresZhejiang Chuangxiang Medical Technology Co., Ltd. · 2018 · cites it directly3descendants
- K183289ClearGrasp SnareFinemedix Co., Ltd. · 2019 · 2 generations on1descendant
- K220846Core-SnareIncore Co., Ltd. · 2022 · 3 generations on0descendants
- K213222Disposable Polypectomy SnareBeijing Zksk Technology Co., Ltd. · 2022 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K950496 | Snare, Flexible, Electrosurgical Cutting & Coagulation Device & Accessories | Boston Scientific Corp | 1995 | — |
| −2 | K992477 | Rotosnare | Inscope, LLC | 1999 | — |
| −1 | K131700 | Sensation Short Throw, Captiflex, Captivator, Captivator II, Profile… | Boston Scientific Corp | 2013 | 8 |
| 0 (this device) | K160637 | Rotatable Snares | Boston Scientific Corporation | 2016 | — |
| +1 | K172758 | Rotatable Snares, Non-Rotatable Snares | Zhejiang Chuangxiang Medical Technology Co., Ltd. | 2018 | — |
| +2 | K183289 | ClearGrasp Snare | Finemedix Co., Ltd. | 2019 | — |
| +3 | K220846 | Core-Snare | Incore Co., Ltd. | 2022 | — |
| +2 | K213222 | Disposable Polypectomy Snare | Beijing Zksk Technology Co., Ltd. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2022 | 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 FDI? 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 FDI device
- #1 K251692 Advanced Tissue Resection Devicescore 10.9 · 1 generation · 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 |
|---|---|---|---|
| * | K131700 | Sensation Short Throw, Captiflex, Captivator, Captivator II, Profile, Single-Use…Summary page 4…Name: Rotatable Snares Common Name: Rotatable Snares Manufacturer: Boston Scientific Corporation Clearance Numbers: K131700 Classification Name: Snare, Flexible Snare, Non-Electrical Regulation Number: 876.… | 2013 |
| † | K133987 | Captivator II,Single-Use Polypectomy Snares | 2014 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K172758 | Rotatable Snares, Non-Rotatable Snares | 2018 | 3 |
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 4.4 years on median.
- 3 of the 5 ancestors have a recall of any class.
- Of its descendants, K172758 (Zhejiang Chuangxiang Medical Technology Co., Ltd., 2018) has gone furthest, with 3 descendants of its own.
- 2 other devices also cite its predicate K131700.
How does its category compare?
All FDI devicesFDI Snare, Flexible: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · FDI
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · FDI
247in 2022
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FDI
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FDI
274in 2025
MAUDE reports naming product code FDI, 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 | 48 |
| 2008 | 2 | — | 0 | 201 |
| 2009 | 1 | — | 0 | 265 |
| 2010 | 0 | — | 1 | 174 |
| 2011 | 1 | — | 0 | 177 |
| 2012 | 1 | — | 0 | 162 |
| 2013 | 3 | 87 | 0 | 191 |
| 2014 | 5 | 47 | 0 | 345 |
| 2015 | 3 | 62 | 1 | 195 |
| 2016 | 1 | — | 0 | 223 |
| 2017 | 1 | — | 0 | 154 |
| 2018 | 4 | 214 | 0 | 181 |
| 2019 | 3 | 100 | 0 | 135 |
| 2020 | 2 | — | 0 | 487 |
| 2021 | 1 | — | 0 | 211 |
| 2022 | 4 | 247 | 0 | 246 |
| 2023 | 1 | — | 0 | 209 |
| 2024 | 0 | — | 0 | 279 |
| 2025 | 0 | — | 2 | 274 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Rotatable Snare is used endoscopically in the removal and/or and cauterization of diminutive polyps, sessile polyps, pedunculated polyps and tissue from within the gastrointestinal tract.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K160637 · printed Nov 4, 2026
Cite this page
510(k) Report. “K160637: Rotatable Snares.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K160637
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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