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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 K223306
Device Name SPRINT Peripheral Nerve Stimulation (PNS) System
Applicant
Spr Therapeutics, Inc.
22901 Millcreek Blvd. Suite 500
Cleveland,  OH  44122
Applicant Contact Kathryn Stager
Correspondent
Spr Therapeutics, Inc.
22901 Millcreek Blvd. Suite 500
Cleveland,  OH  44122
Correspondent Contact Kathryn Stager
Regulation Number882.5890
Classification Product Code
NHI  
Date Received10/27/2022
Decision Date 01/25/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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