The following data is part of a premarket notification filed by Ovesco Endoscopy Ag with the FDA for Ftrd System Set.
| Device ID | K153550 |
| 510k Number | K153550 |
| Device Name: | FTRD System Set |
| Classification | Hemostatic Metal Clip For The Gi Tract |
| Applicant | OVESCO ENDOSCOPY AG DORFACKERSTRASSE 26 Tuebingen, DE 72074 |
| Contact | Marc O. Schurr |
| Correspondent | Martina Krautwald NOVINEON CRO & CONSULTING LTD DORFACKERSTRASSE 26 Tuebingen, DE 72074 |
| Product Code | PKL |
| Subsequent Product Code | FDI |
| Subsequent Product Code | KNS |
| Subsequent Product Code | OCZ |
| CFR Regulation Number | 876.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-12-11 |
| Decision Date | 2016-10-12 |