DEN220006 is an FDA 510(k) submission for the ProdiGI. This device is classified as a Endoscopic Traction Device (Class II - Special Controls, product code QSW).
Submitted by Covidien, LLC (Santa Clara, US). The FDA issued a Not Cleared (DENG) decision on June 13, 2022.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.4410. An Endoscopic Traction Device Is A Prescription Device That Is Endoscopically Applied To Retract Tissue In The Gastrointestinal Tract During Dissection Procedures To Increase Visualization Of The Dissection Plane And Assist In Tissue Resection, Exposure, And Removal..
| 510(k) Number | DEN220006 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | January 14, 2022 |
| Decision Date | June 13, 2022 |
| Days to Decision | 150 days |
| Submission Type | Direct |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | — |
| Product Code | QSW — Endoscopic Traction Device |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.4410 |
| Definition | An Endoscopic Traction Device Is A Prescription Device That Is Endoscopically Applied To Retract Tissue In The Gastrointestinal Tract During Dissection Procedures To Increase Visualization Of The Dissection Plane And Assist In Tissue Resection, Exposure, And Removal. |