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FDA Product Code

FDA Product Code ORR — Clearance Directory

Device Class
Class II
Assigned Panel
Neurology
21 CFR Citation
882.4560

510(k) Clearances — 4 records

K-Number Device Name Applicant Decision Date Clearance Type Summary
K181195 ClearPoint System Mri Interventions, Inc. 2018-11-02 Traditional PDF ↗
K171257 ClearPoint System Mri Interventions, Inc. 2017-10-20 Traditional PDF ↗
K111073 SURGIVISION INC. CLEARPOINT SYSTEM Surgi-Vision, Inc. 2011-06-22 Traditional PDF ↗
K100836 CLEARPOINT SYSTEM Surgivision, Inc. 2010-06-16 Traditional PDF ↗

Product code ORR · Class II · Neurology. Data: openFDA.