K261503
- 510(k) number
- K261503
- Device name
- PuraStat GI
- Applicant
- 3-D Matrix, Inc. MA · US
- Product code
- QAU — Hemostatic Device For Endoscopic Gastrointestinal Us
- Decision date
- 2026-08-03
- Date received
- 2026-05-06
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K261503.pdf
Official FDA record: K261503
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.