The following data is part of a premarket notification filed by Ovesco Endoscopy Ag with the FDA for Gastroduodenal Ftrd Set.
| Device ID | K200684 |
| 510k Number | K200684 |
| Device Name: | Gastroduodenal FTRD Set |
| Classification | Hemostatic Metal Clip For The Gi Tract |
| Applicant | Ovesco Endoscopy AG Friedrich-Miescher-StraBe 9 Tuebingen, DE 72076 |
| Contact | Marc O. Schurr |
| Correspondent | Julia Ehmann novineon CRO GmbH Friedrich-Miescher-StraBe 9 Tuebingen, DE 72076 |
| Product Code | PKL |
| Subsequent Product Code | FDI |
| Subsequent Product Code | KNS |
| CFR Regulation Number | 876.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-03-16 |
| Decision Date | 2020-06-02 |