# P940015: Synvisc One

- Pathway: PMA
- Applicant: Sanofi Genzyme Corp.
- Decided: Aug 8, 1997 after 1,165 days
- Product code: MOZ (Acid, Hyaluronic, Intraarticular)
- Device class: 3
- Recalls of this device: 1 (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
- Dec 11, 2017 · Class II · Z-0607-2018: Contamination with Methylbacterium thiocyanatum

Source page: https://510kreport.com/device/P940015
Methodology: https://510kreport.com/methodology