# DEN240023: SmartFlow Neuro Cannula

- Pathway: De Novo (Direct)
- Applicant: ClearPoint Neuro, Inc.
- Decided: Nov 13, 2024 after 175 days
- Product code: SDG (Brain Intraparenchymal Infusion Cannula)
- Device class: 2
- Regulation: 21 CFR 882.4110
- 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. De Novo decisions do not claim a predicate device.

## Indications for use
The SmartFlow Neuro Cannula, when used with compatible stereotaxic and therapeutic delivery devices, is indicated for intraputaminal administration of eladocagene exuparvovec-tneq for the treatment of adult and pediatric patients with aromatic L-amino acid decarboxylase (AADC) deficiency.

Source page: https://510kreport.com/device/DEN240023
Methodology: https://510kreport.com/methodology