510(k) · Cleared
ClearedRotatable Snares, Non-Rotatable Snares
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zhejiang Chuangxiang Medical Technology Co., Ltd. · FDI Snare, Flexible
Cleared on Mar 7, 2018 as substantially equivalent to K160637 (Boston Scientific Corporation, 2016) after a 175-day review. Its family tree reaches back 4 generations to 1995. 3 later devices descend from it.
- Decided
- Mar 7, 2018
- Review
- 175 days
- Class
- Class II
- Product code
- FDI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K950496 (1995). 6 ancestors in all, the oldest K941750 (1994). 3 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK950496 Snare, Flexible, Electrosurgical Cutting & Coagulation Device &…Boston Scientific Corp · 1995
- 3 generations backK992477 RotosnareInscope, LLC · 1999
- 2 generations backK131700 Sensation Short Throw, Captiflex, Captivator, Captivator II…Boston Scientific Corp · 2013 · Recalled
- 1 generation backK160637 Rotatable SnaresBoston Scientific Corporation · 2016
- This deviceK172758 Rotatable Snares, Non-Rotatable SnaresZhejiang Chuangxiang Medical Technology Co., Ltd. · 2018
- Descendant · cites it directly · 1 of its ownK183289 ClearGrasp SnareFinemedix Co., Ltd. · 2019
- Descendant · 2 generations on · 0 of its ownK220846 Core-SnareIncore Co., Ltd. · 2022
- Descendant · cites it directly · 0 of its ownK213222 Disposable Polypectomy SnareBeijing Zksk Technology Co., Ltd. · 2022
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K950496 | Snare, Flexible, Electrosurgical Cutting & Coagulation Device & Accessories | Boston Scientific Corp | 1995 | — |
| −3 | K992477 | Rotosnare | Inscope, LLC | 1999 | — |
| −2 | K131700 | Sensation Short Throw, Captiflex, Captivator, Captivator II, Profile… | Boston Scientific Corp | 2013 | 8 |
| −1 | K160637 | Rotatable Snares | Boston Scientific Corporation | 2016 | — |
| 0 (this device) | K172758 | Rotatable Snares, Non-Rotatable Snares | Zhejiang Chuangxiang Medical Technology Co., Ltd. | 2018 | — |
| +1 | K183289 | ClearGrasp Snare | Finemedix Co., Ltd. | 2019 | — |
| +2 | K220846 | Core-Snare | Incore Co., Ltd. | 2022 | — |
| +1 | 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 |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K160637 | Rotatable SnaresSummary page 4…ctrosurgical unit and accessories Regulation class: 2 Regulation number:876.4300 Panel: Gastroenterology/Urology Product code: FDI 3. Predicative device 510(k) Number: K160637, Product Name: Rotatable Snares 4. Device description The Polypectomy Snare consists of a flexible wire cable (core wire) and lo… | 2016 |
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 23 years and passes through 4 companies; a new generation was cleared every 4.4 years on median.
- 3 of the 6 ancestors have a recall of any class.
- Of its descendants, K183289 (Finemedix Co., Ltd., 2019) has gone furthest, with 1 descendant of its own.
How does its category compare?
All FDI devicesFDI Snare, Flexible: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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 Polypectomy 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/K172758 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172758: Rotatable Snares, Non-Rotatable Snares.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172758
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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