# K130900: Evicel Application Device

- Pathway: 510(k) (Traditional)
- Applicant: Ethicon Inc (On Behalf of Omrix Biopharaceuticals
- Decided: Aug 13, 2013 after 134 days
- Product code: FMF (Syringe, Piston)
- Device class: 2
- Regulation: 21 CFR 880.5860
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K090162 (2009). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090162: Evicel Application Device, Omrix Biopharmaceuticals, Ltd. (2009) Summary page 1.

## Indications for use
The EVICEL™ Application Device is intended for the simultaneous topical application of the two biological components of EVICEL® Fibrin Sealant via dripping (no air pressure) or via spraying (CO2 pressure only, utilizing the pressure regulator unit) onto the surface.

Source page: https://510kreport.com/device/K130900
Methodology: https://510kreport.com/methodology