510(k) · Cleared
Recalled · Class II · 2021Captivator Single-Use Polypectomy Snares, Captiflex Single-Use Polypectomy 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 Oct 8, 2020 as substantially equivalent to K131700 (Boston Scientific Corp, 2013) after a 41-day review. Its family tree reaches back 3 generations to 1995. It has been recalled once.
- Decided
- Oct 8, 2020
- Review
- 41 days
- Class
- Class II
- Product code
- FDI
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 3 generations to K950496 (1995). 5 ancestors in all, the oldest K941750 (1994). No later device cites it as a predicate yet.
- 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 deviceK202478 Captivator Single-Use Polypectomy Snares, Captiflex Single-Use…Boston Scientific Corporation · 2020
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) | K202478 | Captivator Single-Use Polypectomy Snares, Captiflex Single-Use Polypectomy… | Boston Scientific Corporation | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1996 | 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 |
|---|---|---|---|
| * | K131700 | Sensation Short Throw, Captiflex, Captivator, Captivator II, Profile, Single-Use…Summary page 4…res Rotatable Single-Use Polypectomy Snares Manufacturer: Boston Scientific Corporation Clearance Number: K131700 Common Name: Polypectomy Snares Product Code: FDI, FGX Regulation Class: Class… | 2013 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 19, 2021 | Class II | Z-1168-2021 | Process change control | Packaging Incomplete Seal. Users noted an incomplete pouch seal prior to using the device in a patient. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 25 years and passes through 3 companies; a new generation was cleared every 6.9 years on median.
- 3 of the 5 ancestors have a recall of any class.
- 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. 2020, 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 Captivator and Captiflex Polypectomy Snares are used endoscopically in the removal and/or cauterization 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/K202478 · printed Nov 6, 2026
Cite this page
510(k) Report. “K202478: Captivator Single-Use Polypectomy Snares, Captiflex Single-Use Polypectomy Snares.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K202478
Report an extraction error
Are you the manufacturer?
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