Sparrow Ascent— 510(k) K251246
Substantially EquivalentSpark Biomedical, Inc.
FDA 510(k) clearance K251246 for Sparrow Ascent, Substantially Equivalent on 2025-08-25. Applicant: Spark Biomedical, Inc.. Device class: 2.
Clearance details
- Applicant
- Spark Biomedical, Inc.
- Product code
- Code PZR
- Device class
- Class 2
- Regulation
- 21 CFR 882.5896
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Dallas, TX, US
Recent devices under product code PZR
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