CLEARPOINT SYSTEM— 510(k) K100836

Substantially Equivalent

Surgivision, Inc.

FDA 510(k) clearance K100836 for CLEARPOINT SYSTEM, Substantially Equivalent on 2010-06-16. Applicant: Surgivision, Inc.. Device class: 2.

Clearance details

Applicant: Surgivision, Inc.
Product code: Code ORR
Device class: Class 2
Regulation: 21 CFR 882.4560
Advisory panel: Neurology
Date received: 2010-03-24
Decision date: 2010-06-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, D.C., DC, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.