LINASYS IMAGE-GUIDED LIVER SURGERY SYSTEM— 510(k) K093494

Name: FDA 510(k) clearance K093494
Creator: U.S. Food and Drug Administration
Published: 2010-03-30

Substantially Equivalent

Pathfinder Therapeutics, Inc.

FDA 510(k) clearance K093494 for LINASYS IMAGE-GUIDED LIVER SURGERY SYSTEM, Substantially Equivalent on 2010-03-30. Applicant: Pathfinder Therapeutics, Inc.. Device class: 2.

Clearance details

Applicant: Pathfinder Therapeutics, Inc.
Product code: Code OEW
Device class: Class 2
Regulation: 21 CFR 882.4560
Advisory panel: Neurology
Date received: 2009-11-10
Decision date: 2010-03-30
Decision: Substantially Equivalent
Clearance type: Special
Location: Nashville, TN, US

Download summary PDF View on FDA.gov ↗

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