Chrysalis Intelligence · Sponsors · Neuspera Medical, Inc.

Neuspera Medical, Inc.

San Jose, CA, US · 2 510(k) clearances · 4 PMAs

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 (4)

Total PMA records
4
Originals + supplements
Distinct product codes
1
First decision
2025-06-17
Most recent
2026-04-21
DatePMA #Trade nameTypeCodeDevice nameSpecialty
2026-04-21 P240031-S003 Neuspera Sacral Neuromodulation (SNM) System Normal 180 Day Track EZW
2026-04-03 P240031-S004 Neuspera Sacral Neuromodulation (SNM) System 30-Day Notice EZW
2025-08-15 P240031-S001 Neuspera Sacral Neuromodulation System Normal 180 Day Track No User Fee EZW
2025-06-17 P240031 Neuspera Sacral Neuromodulation System Original EZW
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