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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Neurological Stereotaxic Instrument
510(k) Number K210700
Device Name NaviNetics D1 Stereotactic System
Applicant
Navinetics, Inc.
206 S Broadway
Suite 700
Rochester,  MN  55904
Applicant Contact Patrick Gora
Correspondent
Navinetics, Inc.
206 S Broadway
Suite 700
Rochester,  MN  55904
Correspondent Contact Patrick Gora
Regulation Number882.4560
Classification Product Code
HAW  
Date Received03/09/2021
Decision Date 06/17/2021
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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