Neuspera Neurostimulation System (NNS)

FDA 510(k) K202781 · Neuspera Medical, Inc.

Substantially Equivalent

510(k) numberK202781

Submission

Device name
Neuspera Neurostimulation System (NNS)
Applicant
Neuspera Medical, Inc.
San Jose, CA, US
Received
September 22, 2020
Decision date
August 27, 2021
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
GZF – Stimulator, Peripheral Nerve, Implanted (Pain Relief)
Device class
Class II (moderate risk)
Regulation
21 CFR 882.5870
Specialty
Neurology
Implant
Yes

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More from Bioness, Inc.

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K221303Neuspera Nuity SystemGZF · Traditional 04/11/2023SE

Questions and answers

When was Neuspera Neurostimulation System (NNS) cleared by the FDA?

Neuspera Neurostimulation System (NNS) (K202781) received a 510(k) decision of Substantially Equivalent on August 27, 2021, 339 days after the submission was received.

What is the product code of K202781?

The FDA product code is GZF – Stimulator, Peripheral Nerve, Implanted (Pain Relief), a Class II (moderate risk) device regulated under 21 CFR 882.5870.