Home › Spark Biomedical Inc. › Sparrow Ascent 28 Piece Kit (B2C)
Sparrow Ascent 28 Piece Kit (B2C)
Spark Biomedical Inc. · Model 11-310-K-28 · UDI-DI 00850052017088
PZR
Prescription
1
510(k) clearances
0
Adverse events
1
Recalls
6
Facilities
Description
A starter pack with all the components for acute withdrawal management using Transcutaneous Auricular Neurostimulation (tAN®). This pack includes the Sparrow Ascent Kit and three Sparrow Ascent Left Earpiece Kits. (1) GTIN: 00860005396986 (Base kit containing the Patient Controller, Cable, Belt Clip, QSG, Batteries, seven Alcohol Wipes, and seven Left Earpieces) (3) GTIN: 00860005396993
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-07-02 | Spark Biomedical Inc | Due to manufacturing issue, neurostimulator device may experience "cable disconnect" error message and interruption to stimulation output. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.