DEN200016 is an FDA 510(k) submission for the EndoRotor Device. This device is classified as a Endoscopic Pancreatic Debridement Device (Class II - Special Controls, product code QNE).
Submitted by Interscope, Inc. (Whitinsville, US). The FDA issued a Not Cleared (DENG) decision on December 23, 2020.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.4330. An Endoscopic Pancreatic Debridement Device Is Inserted Via An Endoscope And Placed Through A Cystogastrostomy Fistula Into The Pancreatic Cavity. It Is Intended For Removal Of Necrotic Tissue From A Walled Off Pancreatic Necrosis (wopn) Cavity..
| 510(k) Number | DEN200016 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | March 16, 2020 |
| Decision Date | December 23, 2020 |
| Days to Decision | 282 days |
| Submission Type | Direct |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | - |
| Product Code | QNE - Endoscopic Pancreatic Debridement Device |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.4330 |
| Definition | An Endoscopic Pancreatic Debridement Device Is Inserted Via An Endoscope And Placed Through A Cystogastrostomy Fistula Into The Pancreatic Cavity. It Is Intended For Removal Of Necrotic Tissue From A Walled Off Pancreatic Necrosis (wopn) Cavity. |