510(k) · Cleared
ClearedCore-Snare
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Incore Co., Ltd. · FDI Snare, Flexible
Cleared on Nov 21, 2022 as substantially equivalent to K183289 (Finemedix Co., Ltd., 2019) after a 243-day review. Its family tree reaches back 6 generations to 1995.
- Decided
- Nov 21, 2022
- Review
- 243 days
- Class
- Class II
- Product code
- FDI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K950496 (1995). 11 ancestors in all, the oldest K941750 (1994). No later device cites it as a predicate yet.
- Root · 6 generations backK950496 Snare, Flexible, Electrosurgical Cutting & Coagulation Device &…Boston Scientific Corp · 1995
- 5 generations backK992477 RotosnareInscope, LLC · 1999
- 4 generations backK131700 Sensation Short Throw, Captiflex, Captivator, Captivator II…Boston Scientific Corp · 2013 · Recalled
- 3 generations backK160637 Rotatable SnaresBoston Scientific Corporation · 2016
- 2 generations backK172758 Rotatable Snares, Non-Rotatable SnaresZhejiang Chuangxiang Medical Technology Co., Ltd. · 2018
- 1 generation backK183289 ClearGrasp SnareFinemedix Co., Ltd. · 2019
- This deviceK220846 Core-SnareIncore Co., Ltd. · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K950496 | Snare, Flexible, Electrosurgical Cutting & Coagulation Device & Accessories | Boston Scientific Corp | 1995 | — |
| −5 | K992477 | Rotosnare | Inscope, LLC | 1999 | — |
| −4 | K131700 | Sensation Short Throw, Captiflex, Captivator, Captivator II, Profile… | Boston Scientific Corp | 2013 | 8 |
| −3 | K160637 | Rotatable Snares | Boston Scientific Corporation | 2016 | — |
| −2 | K172758 | Rotatable Snares, Non-Rotatable Snares | Zhejiang Chuangxiang Medical Technology Co., Ltd. | 2018 | — |
| −1 | K183289 | ClearGrasp Snare | Finemedix Co., Ltd. | 2019 | — |
| 0 (this device) | K220846 | Core-Snare | Incore Co., Ltd. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2018 | 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 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 |
|---|---|---|---|
| * | K183289 | ClearGrasp SnareSummary page 5…Traditional 510(K) Ⅲ. Predicate Device Device Name : ClearGrasp Snare Manufacturer : Finemedix Co. Ltd 510(K) Number : K183289 Classification Name : Endoscopic Electrosurgical Unit and Accessories Product Code : FDI Regulatory Class : Class II Regu… | 2019 |
What descends from it?
No later submission names this one as a predicate yet.
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 27 years and passes through 6 companies; a new generation was cleared every 3.7 years on median.
- 4 of the 11 ancestors have a recall of any class.
How does its category compare?
All FDI devicesFDI Snare, Flexible: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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 CORE-SNARE is used endoscopically in the removal of diminutive polyps, sessile polyps, pedunculated polyps and tissue from within the GI tract.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K220846 · printed Nov 6, 2026
Cite this page
510(k) Report. “K220846: Core-Snare.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K220846
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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