Cleared Special

K101979 - EXPLORER LIVER (PASSIVE TRACKING)

K101979 is an FDA 510(k) clearance for EXPLORER LIVER (PASSIVE TRACKING), 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 210-day FDA review.

K101979 · 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
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.

FDA 510(k) Submission Details - K101979

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
95d slower than avg
Panel avg: 115d · This submission: 210d
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.

K101979 · EXPLORER LIVER (PASSIVE TRACKING)
Download PDF FDA Summary Pathfinder Therapeuti…