# K230796: Sparrow Ascent

- Pathway: 510(k) (Traditional)
- Applicant: Spark Biomedical, Inc.
- Decided: Jun 20, 2023 after 90 days
- Product code: PZR (Percutaneous Nerve Stimulator For Opioid Withdrawal)
- Device class: 2
- Regulation: 21 CFR 882.5896
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to DEN170018 (2017). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201873: Sparrow Therapy System, Spark Biomedical, Inc. (2021) Summary page 4.

## Most influential descendants
- K251246: Sparrow Ascent (2025), 0 descendants of its own

## Recalls of this device
- Jul 2, 2025 · Class II · Z-2287-2025: Due to manufacturing issue, neurostimulator device may experience "cable disconnect" error message and interruption to stimulation output.

## Indications for use
The Sparrow Ascent is a transcutaneous nerve field stimulator that is intended to be used in patients experiencing opioid withdrawal in conjunction with standard symptomatic medications and other therapies for opioid withdrawal symptoms under the supervision of trained clinical personnel.

Source page: https://510kreport.com/device/K230796
Methodology: https://510kreport.com/methodology