Cleared Special

K093494 - LINASYS IMAGE-GUIDED LIVER SURGERY SYSTEM

K093494 is an FDA 510(k) clearance for LINASYS IMAGE-GUIDED LIVER SURGERY SYSTEM, manufactured by Pathfinder Therapeutics, Inc.. The device is a Class 2 General & Plastic Surgery device with product code OEW cleared through the Special 510(k) pathway after a 140-day FDA review.

K093494 · Pathfinder Therapeutics, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2010
Decision
140d
Days
Class 2
Risk

K093494 is an FDA 510(k) clearance for the LINASYS IMAGE-GUIDED LIVER SURGERY SYSTEM. Classified as Tracking, Soft Tissue, Intraoperative (product code OEW), Class II - Special Controls.

Submitted by Pathfinder Therapeutics, Inc. (Nashville, US). The FDA issued a Cleared decision on March 30, 2010 after a review of 140 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 882.4560 - the FDA general and plastic surgery device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K093494

510(k) Number K093494 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 10, 2009
Decision Date March 30, 2010
Days to Decision 140 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
25d slower than avg
Panel avg: 115d · This submission: 140d
Pathway characteristics
Modification to existing cleared device.

OEW Device Classification - Class 2, Special Controls

Product Code OEW Tracking, Soft Tissue, Intraoperative
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4560
Definition For Open Liver Surgical Procedures Where Image-guidance May Be Appropriate And Where The Patient Can Tolerate Long Apneic Periods Under General Anesthesia.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

K093494 · LINASYS IMAGE-GUIDED LIVER SURGERY SYSTEM
Download PDF FDA Summary Pathfinder Therapeuti…