# K261503: PuraStat GI

- Pathway: 510(k) (Traditional)
- Applicant: 3-D Matrix, Inc.
- Decided: Aug 3, 2026 after 89 days
- Product code: QAU (Hemostatic Device For Endoscopic Gastrointestinal Use)
- Device class: 2
- Regulation: 21 CFR 878.4456
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to DEN170015 (2018). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K242250: PuraStat, 3-D Matrix Europe SAS (2024) Summary page 5.
- K253924: PuraStat, 3-D Matrix Europe SAS (2026) Summary page 5.

## Indications for use
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.

Source page: https://510kreport.com/device/K261503
Methodology: https://510kreport.com/methodology