The following data is part of a premarket notification filed by Ovesco Endoscopy Ag with the FDA for Liftup (ref. Nr.: 200.56.01), Liftup Kit (ref. Nr.: 200.56.02).
| Device ID | K221385 |
| 510k Number | K221385 |
| Device Name: | LiftUp (Ref. Nr.: 200.56.01), LiftUp Kit (Ref. Nr.: 200.56.02) |
| Classification | Submucosal Injection Agent |
| Applicant | Ovesco Endoscopy AG Friedrich-Miescher-Straße 9 Tuebingen, DE 72076 |
| Contact | Marc O. Schurr |
| Correspondent | Dragana Galevska novineon CRO GmbH Friedrich-Miescher-Straße 9 Tuebingen, DE 72076 |
| Product Code | PLL |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-05-13 |
| Decision Date | 2022-08-11 |