Cleared Traditional

K221303 - Neuspera Nuity System
(FDA 510(k) Clearance)

K221303 · Neuspera Medical, Inc. · Neurology

Apr 2023

Decision

341d

Days

Class 2

Risk

K221303 is an FDA 510(k) clearance for the Neuspera Nuity System. This device is classified as a Stimulator, Peripheral Nerve, Implanted (pain Relief) (Class II — Special Controls, product code GZF).

Submitted by Neuspera Medical, Inc. (San Jose, US). The FDA issued a Cleared decision on April 11, 2023, 341 days after receiving the submission on May 5, 2022.

This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5870.

Submission Details

510(k) Number	K221303 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 05, 2022
Decision Date	April 11, 2023
Days to Decision	341 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Summary PDF