K210098 is an FDA 510(k) clearance for the PuraStat-GI. This device is classified as a Hemostatic Device For Endoscopic Gastrointestinal Use (Class II - Special Controls, product code QAU).
Submitted by 3-D Matrix, Inc. (Newton, US). The FDA issued a Cleared decision on June 25, 2021, 162 days after receiving the submission on January 14, 2021.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4456. Hemostatic Device For Intraluminal Gastrointestinal Use. A Hemostatic Device For Intraluminal Gastrointestinal Use Is A Prescription Device That Is Endoscopically Applied To The Upper And/or Lower Gastrointestinal Tract And Is Intended To Produce Hemostasis Via Absorption Of Fluid Or By Other Physical Means..
| 510(k) Number | K210098 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 14, 2021 |
| Decision Date | June 25, 2021 |
| Days to Decision | 162 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | QAU - Hemostatic Device For Endoscopic Gastrointestinal Use |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4456 |
| Definition | Hemostatic Device For Intraluminal Gastrointestinal Use. A Hemostatic Device For Intraluminal Gastrointestinal Use Is A Prescription Device That Is Endoscopically Applied To The Upper And/or Lower Gastrointestinal Tract And Is Intended To Produce Hemostasis Via Absorption Of Fluid Or By Other Physical Means. |