510(k) · Cleared
ClearedPuraStat GI
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
3-D Matrix, Inc. · QAU Hemostatic Device For Endoscopic Gastrointestinal Use
Cleared on Aug 3, 2026 as substantially equivalent to K242250 (3-D Matrix Europe SAS, 2024) and 1 other predicate after an 89-day review. Its family tree reaches back 5 generations to 2018.
- Decided
- Aug 3, 2026
- Review
- 89 days
- Class
- Class II
- Product code
- QAU
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to DEN170015 (2018). No later device cites it as a predicate yet.
- Root · 5 generations backDEN170015 Hemospray Endoscopic HemostatWilson-Cook Medical, Inc. · 2018
- 4 generations backK210098 PuraStat-GI3-D Matrix, Inc. · 2021
- 3 generations backK222481 PuraStat3-D Matrix, Inc. · 2023
- 2 generations backK242250 PuraStat3-D Matrix Europe SAS · 2024
- 1 generation backK253924 PuraStat3-D Matrix Europe SAS · 2026
- This deviceK261503 PuraStat GI3-D Matrix, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | DEN170015 | Hemospray Endoscopic Hemostat | Wilson-Cook Medical, Inc. | 2018 | — |
| −4 | K210098 | PuraStat-GI | 3-D Matrix, Inc. | 2021 | — |
| −3 | K222481 | PuraStat | 3-D Matrix, Inc. | 2023 | — |
| −2 | K242250 | PuraStat | 3-D Matrix Europe SAS | 2024 | — |
| −1 | K253924 | PuraStat | 3-D Matrix Europe SAS | 2026 | — |
| 0 (this device) | K261503 | PuraStat GI | 3-D Matrix, Inc. | 2026 | — |
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 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
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 |
|---|---|---|---|
| * | K242250 | PuraStatSummary page 5…8.4456 Regulatory Class: II Product Code: QAU Panel: General & Plastic Surgery 3. PREDICATE DEVICES Primary Predicate Device: 3-D Matrix Europe SAS PuraStat (K242250, K253924) 4. DEVICE DESCRIPTION PuraStat GI is a sterile gel composed of synthetic peptide and sterile water for inje… | 2024 |
| * | K253924 | PuraStatSummary page 5…gulatory Class: II Product Code: QAU Panel: General & Plastic Surgery 3. PREDICATE DEVICES Primary Predicate Device: 3-D Matrix Europe SAS PuraStat (K242250, K253924) 4. DEVICE DESCRIPTION PuraStat GI is a sterile gel composed of synthetic peptide and sterile water for injection. It… | 2026 |
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 8 years and passes through 3 companies; a new generation was cleared every 1.6 years on median.
- None of the 5 ancestors has a recall.
- 1 other device also cites its predicate K242250.
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. 2026, 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?
PuraStat is intended for hemostasis of mild and moderate bleeding post ESD or EMR, as an adjunct, bridge, prophylactic or rescue therapy for intraprocedural venous bleeding or prophylactic therapy to prevent post procedure bleeding, and for primary non-variceal gastrointestinal (GI) bleeding. PuraStat is not indicated for arterial Forrest 1a bleeding.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K261503 · printed Nov 4, 2026
Cite this page
510(k) Report. “K261503: PuraStat GI.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K261503
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026