# K221385: LiftUp (Ref. Nr.: 200.56.01), LiftUp Kit (Ref. Nr.: 200.56.02)

- Pathway: 510(k) (Traditional)
- Applicant: Ovesco Endoscopy AG
- Decided: Aug 11, 2022 after 90 days
- Product code: PLL (Submucosal Injection Agent)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The gel is an injection agent for endoscopic mucosal resection (EMR) and/or endoscopic submucosal dissection (ESD).

Source page: https://510kreport.com/device/K221385
Methodology: https://510kreport.com/methodology