TSolution One w/ACG surgical System— 510(k) K150741

Name: FDA 510(k) clearance K150741
Creator: U.S. Food and Drug Administration
Published: 2015-10-22

Substantially Equivalent

THINK Surgical, Inc.

FDA 510(k) clearance K150741 for TSolution One w/ACG surgical System, Substantially Equivalent on 2015-10-22. Applicant: THINK Surgical, Inc.. Device class: 2.

Clearance details

Applicant: THINK Surgical, Inc.
Product code: Code OJP
Device class: Class 2
Regulation: 21 CFR 882.4560
Advisory panel: Neurology
Date received: 2015-03-23
Decision date: 2015-10-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fremont, CA, 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.