Neuspera Neurostimulation System (NNS)— 510(k) K202781

Substantially Equivalent

Neuspera Medical, Inc.

FDA 510(k) clearance K202781 for Neuspera Neurostimulation System (NNS), Substantially Equivalent on 2021-08-27. Applicant: Neuspera Medical, Inc..

Clearance details

Applicant: Neuspera Medical, Inc.
Product code: Code GZF
Advisory panel: Neurology
Date received: 2020-09-22
Decision date: 2021-08-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Jose, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code GZF

product code GZF

Death: 10
Injury: 2,410
Other: 1
Total: 2,421

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.