510(k) · Cleared
Recalled · Class II · 2021Captivator II,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 Jan 24, 2014 as substantially equivalent to K131700 (Boston Scientific Corp, 2013) and 1 other predicate after a 29-day review. Its family tree reaches back 3 generations to 1995. 10 later devices descend from it. It has been recalled once.
- Decided
- Jan 24, 2014
- Review
- 29 days
- Class
- Class II
- Product code
- FDI
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 3 generations to K950496 (1995). 5 ancestors in all, the oldest K941750 (1994). 10 later devices descend from it, 2 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 deviceK133987 Captivator II,Single-Use Polypectomy SnaresBoston Scientific Corporation · 2014
- Descendant · cites it directly · 5 of its ownK172729 Polypectomy SnareHangzhou AGS MedTech Co., Ltd. · 2018
- Descendant · cites it directly · 3 of its ownK172734 Single Use Electrosurgical Snare SD-400Olympus Medical Systems Corp. · 2017 · Recalled
- Descendant · 2 generations on · 1 of its ownK183289 ClearGrasp SnareFinemedix Co., Ltd. · 2019
- Descendant · 2 generations on · 1 of its ownK173673 AcuSnare Polypectomy SnareWilson-Cook Medical, Inc. · 2018
- Descendant · 2 generations on · 0 of its ownK221713 Polypectomy SnareHangzhou AGS MedTech Co., Ltd. · 2023
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K172729Polypectomy SnareHangzhou AGS MedTech Co., Ltd. · 2018 · cites it directly5descendants
- K172734Single Use Electrosurgical Snare SD-400Olympus Medical Systems Corp. · 2017 · cites it directly3descendants
- K183289ClearGrasp SnareFinemedix Co., Ltd. · 2019 · 2 generations on1descendant
- K173673AcuSnare Polypectomy SnareWilson-Cook Medical, Inc. · 2018 · 2 generations on1descendant
- K221713Polypectomy SnareHangzhou AGS MedTech Co., Ltd. · 2023 · 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) | K133987 | Captivator II,Single-Use Polypectomy Snares | Boston Scientific Corporation | 2014 | — |
| +1 | K172729 | Polypectomy Snare | Hangzhou AGS MedTech Co., Ltd. | 2018 | — |
| +1 | K172734 | Single Use Electrosurgical Snare SD-400 | Olympus Medical Systems Corp. | 2017 | 41 |
| +2 | K183289 | ClearGrasp Snare | Finemedix Co., Ltd. | 2019 | — |
| +2 | K173673 | AcuSnare Polypectomy Snare | Wilson-Cook Medical, Inc. | 2018 | — |
| +2 | K221713 | Polypectomy Snare | Hangzhou AGS MedTech Co., Ltd. | 2023 | — |
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 |
|---|---|---|
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2022 | 3 | 0 |
| 2023 | 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? (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 |
|---|---|---|---|
| * | K131700 | Sensation Short Throw, Captiflex, Captivator, Captivator II, Profile, Single-Use…Summary page 1…Captivator 11, Single-Use Polypectomy Snares Profle, Single-Use Polypectomy Snares Manufacturer and Clearance Number: Boston Scientific Corporation, K 13 1700 Classification Name: 1) Snare, Flexible, 2) Snare,,Non-Eleetrical Regulation Number: 1)876.4300, 2) 876.4730 Product Cod… | 2013 |
| * | K955650 | Olympus SD Series SnaresSummary page 1…tion Number: 1)876.4300, 2) 876.4730 Product Code: 1) EDI, 2) FOX Classification: Class 11 Trade Name: SnareMaster Manufacturer and Clearance Number: Olympus, K955650 Classification Name: 1) Snare, Flexible, 2) Electrode, electrosurgical. active, urological Regulation Number: 876.4300 Prod… | 1996 |
What descends from it? (10)
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 19, 2021 | Class II | Z-1169-2021 | 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 19 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, K172729 (Hangzhou AGS MedTech Co., Ltd., 2018) has gone furthest, with 5 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. 2014, 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 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/K133987 · printed Nov 5, 2026
Cite this page
510(k) Report. “K133987: Captivator II,Single-Use Polypectomy Snares.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K133987
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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