# P190006: Axonics Sacral Neuromodulation System

- Pathway: PMA
- Applicant: Boston Scientific Corporation
- Decided: Sep 6, 2019 after 186 days
- Product code: QON (Implanted Electrical Device Intended For Treatment Of Fecal Incontinence)
- Device class: 3
- Regulation: 21 CFR 876.5270
- 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
- Jul 15, 2024 · Class II · Z-0198-2027: Retroactively Reported: 10mL luer lock syringes included in kit may leak , break or experience other issues that may pose a risk to users.

Source page: https://510kreport.com/device/P190006
Methodology: https://510kreport.com/methodology