Chrysalis Intelligence · Sponsors · Spark Biomedical, Inc.

Spark Biomedical, Inc.

Dallas, TX, US · 3 510(k) clearances · 1 recalls

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Total clearances
3
2021-01-02 → 2025-08-25
Last 12 months
0
Product codes
1
Most recent
2025-08-25
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
PZR Percutaneous Nerve Stimulator For Opioid Withdrawal Class II Neurology 3 2025-08-25
Safety

Recalls (1)

Class I (serious)
0
Risk of injury / death
Total recalls
1
Currently ongoing
1
Most recent
2025-07-02
DateSeverityStatusRecall # ProductCodeReason
2025-07-02 Class II Ongoing Z-2287-2025 Sparrow Ascent Patient Controller, REF's: 11-110-K, 11-310-K, 11-320-K, 11-321-K, 11-310-K-28, 11-320-K-28, 11-321-K-28 — Due to manufacturing issue, neurostimulator device may experience "cable disconnect" error message and interruption to stimulation output.
Filings

All 510(k) clearances (3)

Date K-number Device Code Class Specialty
2025-08-25 K251246 Sparrow Ascent PZR Class II Neurology
2023-06-20 K230796 Sparrow Ascent PZR Class II Neurology
2021-01-02 K201873 Sparrow Therapy System PZR Class II Neurology
Data source: openFDA · Generated 2026-08-26 09:36 · Last ingest 2026-08-26T13:35:45.365163 · Pipeline: Chrysalis Intelligence