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510(k) K101979

Device
EXPLORER LIVER (PASSIVE TRACKING)
Applicant
PATHFINDER THERAPEUTICS, INC.
510(k) number
K101979
Product code
OEW  
Decision
Substantially Equivalent (SESE)
Decision date
2011-02-09
Date received
2010-07-14
Regulation
882.4560
Classification name
Tracking, Soft Tissue, Intraoperative
Medical specialty
Neurology
Review panel
General & Plastic Surgery
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
SENHU LI
Address
2969 Armory Dr. Suite 100a Nashville TN US 37204 37204

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code OEW  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K143024CAS-One LiverCascination AG2015-04-28
K093494LINASYS IMAGE-GUIDED LIVER SURGERY SYSTEMPathfinder Therapeutics, Inc.2010-03-30
K071063LINASYSPathfinder Therapeutics, Inc.2007-12-20

Legacy Summary#

summary

FDA Review#

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