Chrysalis Intelligence · Sponsors · Neuspera Medical, Inc.

Neuspera Medical, Inc.

San Jose, CA, US · 2 510(k) clearances · 5 PMAs

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Total clearances
2
2021-08-27 → 2023-04-11
Last 12 months
0
Product codes
1
Most recent
2023-04-11
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
GZF Stimulator, Peripheral Nerve, Implanted (Pain Relief) Class II Neurology 2 2023-04-11
Class III

PMA approvals (5)

Total PMA records
5
Originals + supplements
Distinct product codes
1
First decision
2025-06-17
Most recent
2026-08-21
DatePMA #Trade nameTypeCodeDevice nameSpecialty
2026-08-21 P240031-S005 Neuspera Sacral Neuromodulation (SNM) System Real-Time Process EZW Stimulator, Electrical, Implantable, For Incontinence Gastroenterology, Urology
2026-04-21 P240031-S003 Neuspera Sacral Neuromodulation (SNM) System Normal 180 Day Track EZW Stimulator, Electrical, Implantable, For Incontinence Gastroenterology, Urology
2026-04-03 P240031-S004 Neuspera Sacral Neuromodulation (SNM) System 30-Day Notice EZW Stimulator, Electrical, Implantable, For Incontinence Gastroenterology, Urology
2025-08-15 P240031-S001 Neuspera Sacral Neuromodulation System Normal 180 Day Track No User Fee EZW Stimulator, Electrical, Implantable, For Incontinence Gastroenterology, Urology
2025-06-17 P240031 Neuspera Sacral Neuromodulation System Original EZW Stimulator, Electrical, Implantable, For Incontinence Gastroenterology, Urology
Filings

All 510(k) clearances (2)

Date K-number Device Code Class Specialty
2023-04-11 K221303 Neuspera Nuity System GZF Class II Neurology
2021-08-27 K202781 Neuspera Neurostimulation System (NNS) GZF Class II Neurology
Data source: openFDA · Generated 2026-09-08 09:57 · Last ingest 2026-09-08T13:56:10.065722 · Pipeline: Chrysalis Intelligence