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510(k) K101979

EXPLORER LIVER (PASSIVE TRACKING) by Pathfinder Therapeutics, Inc. — Product Code OEW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 9, 2011
Date Received
July 14, 2010
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tracking, Soft Tissue, Intraoperative
Device Class
Class II
Regulation Number
882.4560
Review Panel
SU
Submission Type

For open liver surgical procedures where image-guidance may be appropriate and where the patient can tolerate long apneic periods under general anesthesia.

Other clearances by Pathfinder Therapeutics, Inc.

  • K093494 — LINASYS IMAGE-GUIDED LIVER SURGERY SYSTEM (March 30, 2010)
  • K082228 — PLANISIGHT LINASYS (September 22, 2008)
  • K071063 — LINASYS (December 20, 2007)

Other clearances for product code OEW

  • K143024 — CAS-One Liver (April 28, 2015)
  • K093494 — LINASYS IMAGE-GUIDED LIVER SURGERY SYSTEM (March 30, 2010)
  • K071063 — LINASYS (December 20, 2007)