SPRINT Peripheral Nerve Stimulation System, Extensa, SPRINT Peripheral Nerve Stimulation System, Endura, SPRINT Clinical Programmer Kit— 510(k) K181422

Name: FDA 510(k) clearance K181422
Creator: U.S. Food and Drug Administration
Published: 2018-07-31

Substantially Equivalent

Spr Therapeutics, Inc.

FDA 510(k) clearance K181422 for SPRINT Peripheral Nerve Stimulation System, Extensa, SPRINT Peripheral Nerve Stimulation System, Endura, SPRINT Clinical Programmer Kit, Substantially Equivalent on 2018-07-31. Applicant: Spr Therapeutics, Inc.. Device class: 2.

Clearance details

Applicant: Spr Therapeutics, Inc.
Product code: Code NHI
Device class: Class 2
Regulation: 21 CFR 882.5890
Advisory panel: Neurology
Date received: 2018-05-31
Decision date: 2018-07-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cleveland, OH, US

Download summary PDF View on FDA.gov ↗

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