De Novo · Granted
GrantedHemospray Endoscopic Hemostat
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wilson-Cook Medical, Inc. · QAU Hemostatic Device For Endoscopic Gastrointestinal Use
Granted on May 7, 2018 as a new device type through De Novo after a 424-day review. 11 later devices descend from it.
- Decided
- May 7, 2018
- Review
- 424 days
- Class
- Class II
- Product code
- QAU
- Recalls
- None
11 later devices descend from it, 5 citing it directly.
- This deviceDEN170015 Hemospray Endoscopic HemostatWilson-Cook Medical, Inc. · 2018
- Descendant · cites it directly · 4 of its ownK210098 PuraStat-GI3-D Matrix, Inc. · 2021
- Descendant · 2 generations on · 3 of its ownK222481 PuraStat3-D Matrix, Inc. · 2023
- Descendant · 3 generations on · 2 of its ownK242250 PuraStat3-D Matrix Europe SAS · 2024
- Descendant · 4 generations on · 1 of its ownK253924 PuraStat3-D Matrix Europe SAS · 2026
- Descendant · cites it directly · 1 of its ownK190677 EndoClotEndoclot Plus Co., Ltd. · 2021
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K210098PuraStat-GI3-D Matrix, Inc. · 2021 · cites it directly4descendants
- K222481PuraStat3-D Matrix, Inc. · 2023 · 2 generations on3descendants
- K242250PuraStat3-D Matrix Europe SAS · 2024 · 3 generations on2descendants
- K253924PuraStat3-D Matrix Europe SAS · 2026 · 4 generations on1descendant
- K190677EndoClotEndoclot Plus Co., Ltd. · 2021 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN170015 | Hemospray Endoscopic Hemostat | Wilson-Cook Medical, Inc. | 2018 | — |
| +1 | K210098 | PuraStat-GI | 3-D Matrix, Inc. | 2021 | — |
| +2 | K222481 | PuraStat | 3-D Matrix, Inc. | 2023 | — |
| +3 | K242250 | PuraStat | 3-D Matrix Europe SAS | 2024 | — |
| +4 | K253924 | PuraStat | 3-D Matrix Europe SAS | 2026 | — |
| +1 | K190677 | EndoClot | Endoclot Plus Co., Ltd. | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 3 | 0 |
| 2026 | 3 | 0 |
Sources: FDA De Novo 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 QAU? 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 QAU device
- #1 K242250 PuraStatscore 14.8 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it? (11)
See all 115 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?
- Of its descendants, K210098 (3-D Matrix, Inc., 2021) has gone furthest, with 4 descendants of its own.
How does its category compare?
All QAU devicesQAU Hemostatic Device For Endoscopic Gastrointestinal Use: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · QAU
3in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · QAU
211in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QAU
2in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · QAU
121in 2025
MAUDE reports naming product code QAU, 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 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 56 |
| 2019 | 0 | — | 0 | 218 |
| 2020 | 1 | — | 0 | 73 |
| 2021 | 2 | — | 0 | 112 |
| 2022 | 1 | — | 0 | 135 |
| 2023 | 1 | — | 0 | 132 |
| 2024 | 3 | 211 | 2 | 154 |
| 2025 | 0 | — | 0 | 121 |
| 2026 | 3 | 89 | 1 | — |
What is it indicated for?
The COOK Hemospray® Endoscopic Hemostat is used for hemostasis of non-variceal gastrointestinal bleeding.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/DEN170015 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN170015: Hemospray Endoscopic Hemostat.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN170015
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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