510(k) · Cleared
ClearedAcuSnare Polypectomy Snare - Duckbill
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wilson-Cook Medical, Inc. · FDI Snare, Flexible
Cleared on Jul 18, 2019 as substantially equivalent to K173673 (Wilson-Cook Medical, Inc., 2018) after a 90-day review. Its family tree reaches back 6 generations to 1995.
- Decided
- Jul 18, 2019
- Review
- 90 days
- Class
- Class II
- Product code
- FDI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K950496 (1995). 9 ancestors in all, the oldest K851958 (1985). 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 backK133987 Captivator II,Single-Use Polypectomy SnaresBoston Scientific Corporation · 2014 · Recalled
- 2 generations backK172734 Single Use Electrosurgical Snare SD-400Olympus Medical Systems Corp. · 2017 · Recalled
- 1 generation backK173673 AcuSnare Polypectomy SnareWilson-Cook Medical, Inc. · 2018
- This deviceK191048 AcuSnare Polypectomy Snare - DuckbillWilson-Cook Medical, Inc. · 2019
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 | K133987 | Captivator II,Single-Use Polypectomy Snares | Boston Scientific Corporation | 2014 | 1 |
| −2 | K172734 | Single Use Electrosurgical Snare SD-400 | Olympus Medical Systems Corp. | 2017 | 41 |
| −1 | K173673 | AcuSnare Polypectomy Snare | Wilson-Cook Medical, Inc. | 2018 | — |
| 0 (this device) | K191048 | AcuSnare Polypectomy Snare - Duckbill | Wilson-Cook Medical, Inc. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K173673 | AcuSnare Polypectomy SnareSummary page 4…iew Panel: Gastroenterology-Urology Predicate Device Name: AcuSnare Polypectomy Snare 510(k) Number: K173673 Date: Cleared August 24, 2018 Device Description The AcuSnare Polypectomy Snare – Duckbill (ASDB) i… | 2018 |
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 24 years and passes through 5 companies; a new generation was cleared every 3.9 years on median.
- 6 of the 9 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. 2019, 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 AcuSnare Polypectomy Snare – Duckbill (ASDB) device is used endoscopically in the removal and cauterization of sessile polyps and pedunculated polyps from within the gastrointestinal tract.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K191048 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191048: AcuSnare Polypectomy Snare - Duckbill.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191048
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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