# K071126: Cryoseal FS Applicator System

- Pathway: 510(k) (Traditional)
- Applicant: Thermogenesis Corp.
- Decided: Aug 16, 2007 after 115 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: 4 generations back to K872565 (1987). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K014088: Duploreach, Baxter Healthcare Corp (2002) Summary page 1.
- K020666: Duploject Easy-Prep System 1ML, 2ML, 5ML, Baxter Healthcare Corp (2002) Summary page 1.

## Indications for use
The CryoSeal® FS Applicator System is intended for the simultaneous application of the two components of CryoSeal FS (fibrin sealant) onto the incised liver surface in patients undergoing liver resection.

Source page: https://510kreport.com/device/K071126
Methodology: https://510kreport.com/methodology