The following data is part of a premarket notification filed by Ovesco Endoscopy Ag with the FDA for Stentfix Otsc System Set.
| Device ID | K183309 |
| 510k Number | K183309 |
| Device Name: | Stentfix OTSC System Set |
| Classification | Hemostatic Metal Clip For The Gi Tract |
| Applicant | Ovesco Endoscopy AG Dorfackerstrasse 26 Tuebingen, DE 72074 |
| Contact | Marc O. Schurr |
| Correspondent | Julia Ehmann novineon CRO & Consulting Ltd Dorfackerstrasse 26 Tuebingen, DE 72074 |
| Product Code | PKL |
| CFR Regulation Number | 876.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-11-29 |
| Decision Date | 2019-10-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04260206311096 | K183309 | 000 |
| 04260206311287 | K183309 | 000 |