Device product
EndoTool SubQ (Versions 1.7.1, 1.7.4, 1.7.5)
Z-0354-2020
Product summary
- Event
- Event 83926
- Status
- Terminated
- Classification
- Class II
- Quantity
- 6 units
- Official record key
device-enforcement:Z-0354-2020
Official wording
Reason: Product was distributed prior to approval or clearance from FDA.
Code information: versions: v 1.7.1, 1.7.4, 1.7.5
Distribution pattern: SC, IL IN, CA
Derived failure modes
-
Unknown
Product was distributed prior to approval or clearance from FDA.