# K052173: Vitagel Surgical Hemostat Spray Set

- Pathway: 510(k) (Traditional)
- Applicant: Orthovita, Inc.
- Decided: Oct 19, 2005 after 70 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Micromedics FibriJet Aerosol Applicator: named in the summary without a submission number
- (no number) Baxter Tissomat and Spray Set: named in the summary without a submission number

## Indications for use
The Vitagel TM Surgical Hemostat Spray Set is intended for use in the application (by spraying) of the two components of Vitagel' Surgical Hemostat onto wound surfaces.

Source page: https://510kreport.com/device/K052173
Methodology: https://510kreport.com/methodology