# K030032: Crosseal Application Device

- Pathway: 510(k) (Traditional)
- Applicant: Omrix Biopharmaceuticals, Inc.
- Decided: Mar 21, 2003 after 77 days
- Product code: FMI (Needle, Hypodermic, Single Lumen)
- Device class: 2
- Regulation: 21 CFR 880.5570
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K872565 (1987). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K973510: Duploject (0.5/1.0 ML, 2.0 ML, 5.0 ML), Immuno-U.S., Inc. (1997) Summary page 1.
- K981089: Tissomat and Spray Set, Baxter Healthcare Corp (2000) Summary page 1.

## Recalls of this device
- Aug 6, 2004 · Not classified · Z-1497-04: 5 mL Crosseal fibrin sealant (human) is difficult to expel from the device resulting in product leakage from the vial insertion port .

## Indications for use
The CrossealTMApplication Device is intended for the simultaneous topical application of the two biological components of CrossealTMFibrin Sealant via dripping (no air pressure) or via spraying (with air pressure utilizing the pressure regulator unit) onto the surface of the liver in patients undergoing liver surgery.

Source page: https://510kreport.com/device/K030032
Methodology: https://510kreport.com/methodology