# K992351: Sealouette Fibrin Sealant Applicator

- Pathway: 510(k) (Traditional)
- Applicant: Biosurgical Corp.
- Decided: Oct 8, 1999 after 86 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 K964597 (1997). 1 ancestor in all.
3 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K964597: Biosurgical, Corp. Multi Chamber Suction Syringe, Biosurgical Corp. (1997) Summary page 2.
- (no number) Immuno-U.S. Duploject®: named in the summary without a submission number

## Most influential descendants
- K020666: Duploject Easy-Prep System 1ML, 2ML, 5ML (2002), 1 descendant of its own
- K014088: Duploreach (2002), 1 descendant of its own
- K071126: Cryoseal FS Applicator System (2007), 0 descendants of its own

## Indications for use
For the mixing, and one-to-one (1:1) delivery, of fibrin sealant for medical applications. It can also be attached to standard hospital wall suction for removal of debris, excess tissue or foreign particles in the wound.

Source page: https://510kreport.com/device/K992351
Methodology: https://510kreport.com/methodology