ProdiGI
Endoscopic Traction Device
Covidien LLC
The following data is part of a De Novo classification by Covidien Llc with the FDA for Prodigi.
Pre-market Notification Details
| DeNovo ID | DEN220006 |
| Device Name: | ProdiGI |
| Classification | Endoscopic Traction Device |
| Applicant | Covidien LLC 3062 Bunker Hill Lane Santa Clara, CA 95054 |
| Contact | Liron Bar Yaakov |
| Product Code | QSW |
| CFR Regulation Number | 876.4410 [🔎] |
| Decision | Granted (DENG) |
| 510(k) Premarket Notification | Device Classification Under Section 513(f)(2)(De Novo) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Lin |
| Review Advisory Board | Gastroenterology/Urology |
| Classification Advisory | Gastroenterology/Urology |
| Type | Direct |
| Date Received | 2022-01-14 |
| Decision Date | 2022-06-13 |
| Reclassification Order: | Reclassification Order |
NIH GUDID Devices
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