The following data is part of a premarket notification filed by 3-d Matrix, Inc. with the FDA for Purastat-gi.
| Device ID | K210098 |
| 510k Number | K210098 |
| Device Name: | PuraStat-GI |
| Classification | Hemostatic Device For Endoscopic Gastrointestinal Use |
| Applicant | 3-D Matrix, Inc. 1234 Chestnut St., Suite 205 Newton, MA 02464 |
| Contact | Lisa Spirio |
| Correspondent | Stephen P. Rhodes Streamline Regulatory 3502 Dundee Driveway Chevy Chase, MD 20815 |
| Product Code | QAU |
| CFR Regulation Number | 878.4456 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-01-14 |
| Decision Date | 2021-06-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860001820874 | K210098 | 000 |
| 00860001820867 | K210098 | 000 |