# P050044: Vitagel RT3 Sutgical Hemostat

- Pathway: PMA
- Applicant: Stryker Corp.
- Decided: Jun 16, 2006 after 198 days
- Product code: PMX (Absorbable Collagen Hemostatic Agent With Thrombin)
- Device class: 3
- Regulation: 21 CFR 878.4490
- Recalls of this device: 2 (0 Class I)
- 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. PMA decisions do not claim a predicate device.

## Recalls of this device
- Feb 26, 2015 · Class II · Z-1353-2015: Several shipments of Vitagel product (a surgical hemostat) required to be stored at 2 -8 degrees Celsius (C) were not delivered to customers within the validated delivery time.
- Jul 26, 2012 · Class II · Z-0431-2013: When preparing plasma using VitaPrep, it was reported that a small amount of blood collected in the bottom of the centrifuge cup following the centrifugation step. Firm has since discovered that if bl

Source page: https://510kreport.com/device/P050044
Methodology: https://510kreport.com/methodology