510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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K101979Substantially Equivalent

Explorer Liver (Passive Tracking)

Pathfinder Therapeutics, Inc., Nashville TN / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K101979 is the FDA 510(k) clearance record for EXPLORER LIVER (PASSIVE TRACKING), a class II device, cleared for Pathfinder Therapeutics, Inc. on under FDA product code OEW (Tracking, Soft Tissue, Intraoperative). FDA's definition for product code OEW reads: "For open liver surgical procedures where image-guidance may be appropriate and where the patient can tolerate long apneic periods under general anesthesia". FDA records list 4 510(k) clearances for Pathfinder Therapeutics, Inc., from to . As of , FDA records show no recalls naming K101979.

Clearance record

Decision date
Received
(210 days to decision)
Product code
OEW Tracking, Soft Tissue, Intraoperative
Regulation
21 CFR 882.4560
Device class
Class II
Review panel
Neurology
Applicant
Pathfinder Therapeutics, Inc. 2969 Armory Dr., Nashville TN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OEW

Trailing 12 months

FDA records hold no clearances under product code OEW in the trailing twelve months.

FDA records show no clearances under product code OEW in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code OEW, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260