# K070575: Evicel Application Device

- Pathway: 510(k) (Traditional)
- Applicant: Omrix Biopharmaceuticals, Ltd.
- Decided: May 29, 2007 after 90 days
- Product code: FMF (Syringe, Piston)
- Device class: 2
- Regulation: 21 CFR 880.5860
- Recalls of this device: 1 (0 Class I)
- 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.

## Recalls of this device
- Mar 7, 2018 · Class II · Z-1534-2018: Products labeled for distribution outside the United States may have been distributed to customers in the United States.

## Indications for use
The EVICELTM Application Device is intended for the simultaneous topical application or the two biological components of EVICELTM fibrin sealant via dripping (no air Pressure) or via spraying (with air or CO 2 pressure utilizing the pressure regulator unit) onto the surface,

Source page: https://510kreport.com/device/K070575
Methodology: https://510kreport.com/methodology