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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Nerve, Electrical, Percutaneous (Pens), For Pain Relief
510(k) Number K181422
Device Name SPRINT Peripheral Nerve Stimulation System, Extensa, SPRINT Peripheral Nerve Stimulation System, Endura, SPRINT Clinical Programmer Kit
Applicant
SPR Therapeutics, Inc.
22901 Millcreek Blvd, Suite 110
Cleveland,  OH  44122
Applicant Contact Kathryn Stager
Correspondent
SPR Therapeutics, Inc.
22901 Millcreek Blvd, Suite 110
Cleveland,  OH  44122
Correspondent Contact Kathryn Stager
Regulation Number882.5890
Classification Product Code
NHI  
Date Received05/31/2018
Decision Date 07/31/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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