Cleared Special

K101979 - EXPLORER LIVER (PASSIVE TRACKING) (FDA 510(k) Clearance)

Class II General & Plastic Surgery device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K101979 · Pathfinder Therapeutics, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2011
Decision
210d
Days
Class 2
Risk

K101979 is an FDA 510(k) clearance for the EXPLORER LIVER (PASSIVE TRACKING). 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 February 9, 2011 after a review of 210 days - an extended review cycle.

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.

View all Pathfinder Therapeutics, Inc. devices

Submission Details

510(k) Number K101979 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 14, 2010
Decision Date February 09, 2011
Days to Decision 210 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
96d slower than avg
Panel avg: 114d · This submission: 210d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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.