# K210098: PuraStat-GI

- Pathway: 510(k) (Traditional)
- Applicant: 3-D Matrix, Inc.
- Decided: Jun 25, 2021 after 162 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: 1 generation back to DEN170015 (2018). 1 ancestor in all.
4 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN170015: Hemospray Endoscopic Hemostat, Wilson-Cook Medical, Inc. (2018) Summary page 4.

## Most influential descendants
- K222481: PuraStat (2023), 3 descendants of its own
- K242250: PuraStat (2024), 2 descendants of its own
- K253924: PuraStat (2026), 1 descendant of its own
- K261503: PuraStat GI (2026), 0 descendants of its own

## Indications for use
PuraStat-GI 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.

Source page: https://510kreport.com/device/K210098
Methodology: https://510kreport.com/methodology