PuraStat GI— 510(k) K261503
Substantially Equivalent3-D Matrix, Inc.
FDA 510(k) clearance K261503 for PuraStat GI, Substantially Equivalent on 2026-08-03. Applicant: 3-D Matrix, Inc.. Device class: 2.
Summary
3-D Matrix's PuraStat GI is filed under product code QAU, hemostatic devices for endoscopic gastrointestinal use. The record gives no sizes or model numbers.
Class II, 21 CFR 878.4456. General and Plastic Surgery is both the classification panel and the review panel, and it came in as a Traditional 510(k).
3-D Matrix filed from Newton, Massachusetts. The decision came 89 calendar days after FDA received it (May 6 to August 3, 2026), and it was substantially equivalent.
Clearance details
- Applicant
- 3-D Matrix, Inc.
- Product code
- Product code QAU
- Device class
- Class 2
- Regulation
- 21 CFR 878.4456
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Newton, MA, US
Recent devices under product code QAU
view allMore clearances from 3-D Matrix, Inc.
view allAdverse events under product code QAU
product code QAU- Death
- 6
- Injury
- 135
- Malfunction
- 621
- Total
- 762
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.