# K090162: Evicel Application Device

- Pathway: 510(k) (Special)
- Applicant: Omrix Biopharmaceuticals, Ltd.
- Decided: Feb 20, 2009 after 29 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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.

## Most influential descendants
- K130900: Evicel Application Device (2013), 0 descendants of its own

## Recalls of this device
- Jul 2, 2012 · Class II · Z-0111-2013: Ethicon and Omrix Biopharmaceuticals have received reports of air or gas embolism occuring in association with the use of spray devices employing a pressure regulator to administer EVICEL; these event

## Indications for use
The EVICELTM Application Device is intended for the simultaneous topical application of the two biological components of EVICELTM fibrin sealant dripping (no air Pressure) or via spraying (with air or C0 pressure utilizing via the pressure regulator unit) onto the surface.

Source page: https://510kreport.com/device/K090162
Methodology: https://510kreport.com/methodology