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.
Clearance details
- Applicant
- 3-D Matrix, Inc.
- Product code
- 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.