DEN170015 is an FDA 510(k) submission for the Hemospray Endoscopic Hemostat. This device is classified as a Hemostatic Device For Endoscopic Gastrointestinal Use (Class II - Special Controls, product code QAU).
Submitted by Wilson-Cook Medical, Inc. (Winston-Salem, US). The FDA issued a Not Cleared (DENG) decision on May 7, 2018.
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 | DEN170015 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | March 09, 2017 |
| Decision Date | May 07, 2018 |
| Days to Decision | 424 days |
| Submission Type | Direct |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| 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. |