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510(k) K100836

Device
CLEARPOINT SYSTEM
Applicant
SURGIVISION, INC.
510(k) number
K100836
Product code
ORR  
Decision
Substantially Equivalent (SESE)
Decision date
2010-06-16
Date received
2010-03-24
Regulation
882.4560
Classification name
Neurological Stereotaxic Instrument, Real-time Intraoperative Mri
Medical specialty
Neurology
Review panel
Radiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
JOHN J SMITH M.D., J.D.
Address
Columbia Sq. 555 Thirteenth St., NW Washington, D.C. DC US 20004 20004

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code ORR  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K181195ClearPoint SystemMri Interventions, Inc.2018-11-02
K171257ClearPoint SystemMri Interventions, Inc.2017-10-20
K111073SURGIVISION INC. CLEARPOINT SYSTEMSurgi-Vision, Inc.2011-06-22

Legacy Summary#

summary

FDA Review#

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