510(k) · Cleared
ClearedCook Ireland Sonnet Polypectomy Snare
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cook Ireland, Ltd. · FDI Snare, Flexible
Cleared on Mar 31, 2005 as substantially equivalent to K851958 (Wilson-Cook Medical, Inc., 1985) and 1 other predicate after a 52-day review. Its family tree reaches back 1 generation to 1985. 9 later devices descend from it.
- Decided
- Mar 31, 2005
- Review
- 52 days
- Class
- Class II
- Product code
- FDI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K851958 (1985). 2 ancestors in all. 9 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK851958 Rotatable Polypectomy Snare Pos-1Wilson-Cook Medical, Inc. · 1985 · Recalled
- This deviceK050294 Cook Ireland Sonnet Polypectomy SnareCook Ireland, Ltd. · 2005
- Descendant · cites it directly · 7 of its ownK070315 Lina Loop, Models: EL-160-4, EL-160-8, EL-200-4, EL-200-8Lina Medical Aps · 2007 · Recalled
- Descendant · 2 generations on · 3 of its ownK111059 Gyrus Acmil Bipolarlaproscopic Loop (PKS Bill)Gyrus Acmi, Inc. · 2011
- Descendant · 3 generations on · 1 of its ownK122605 PKS BillGyrus Acmi, Inc. · 2012
- Descendant · 2 generations on · 0 of its ownK254303 Karl Storz SupraloopKarl Storz SE & CO. KG · 2026
- Descendant · 3 generations on · 0 of its ownK142525 PK Lap LoopOlympus Winter & Ibe GmbH · 2014
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K070315Lina Loop, Models: EL-160-4, EL-160-8, EL-200-4, EL-200-8Lina Medical Aps · 2007 · cites it directly7descendants
- K111059Gyrus Acmil Bipolarlaproscopic Loop (PKS Bill)Gyrus Acmi, Inc. · 2011 · 2 generations on3descendants
- K122605PKS BillGyrus Acmi, Inc. · 2012 · 3 generations on1descendant
- K254303Karl Storz SupraloopKarl Storz SE & CO. KG · 2026 · 2 generations on0descendants
- K142525PK Lap LoopOlympus Winter & Ibe GmbH · 2014 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K851958 | Rotatable Polypectomy Snare Pos-1 | Wilson-Cook Medical, Inc. | 1985 | 3 |
| 0 (this device) | K050294 | Cook Ireland Sonnet Polypectomy Snare | Cook Ireland, Ltd. | 2005 | — |
| +1 | K070315 | Lina Loop, Models: EL-160-4, EL-160-8, EL-200-4, EL-200-8 | Lina Medical Aps | 2007 | 3 |
| +2 | K111059 | Gyrus Acmil Bipolarlaproscopic Loop (PKS Bill) | Gyrus Acmi, Inc. | 2011 | — |
| +3 | K122605 | PKS Bill | Gyrus Acmi, Inc. | 2012 | — |
| +2 | K254303 | Karl Storz Supraloop | Karl Storz SE & CO. KG | 2026 | — |
| +3 | K142525 | PK Lap Loop | Olympus Winter & Ibe GmbH | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K851958 | Rotatable Polypectomy Snare Pos-1Summary page 2…devices. Manufacturer Device 5 10(k) Wiison-Cook Wilson-Cook Snare K851958 Horizons International Corp. Horizons Polypectomy Snare K01 1667… | 1985 |
| * | K011667 | Horizons International Polypectomy SnaresSummary page 2…5 10(k) Wiison-Cook Wilson-Cook Snare K851958 Horizons International Corp. Horizons Polypectomy Snare K01 1667 Public Health Service… | 2001 |
What descends from it? (9)
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?
How does its category compare?
All FDI devicesFDI Snare, Flexible: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 Sonnet TM Polypectomy Snare is a monopolar electrosurgical device used with an electrical unit for endoscopic polypectomy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050294 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050294: Cook Ireland Sonnet Polypectomy Snare.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050294
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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