510(k) K101979
K101979 is an FDA 510(k) premarket notification submitted by Pathfinder Therapeutics, Inc. for the device "EXPLORER LIVER (PASSIVE TRACKING)". The FDA issued a decision of Substantially Equivalent on February 9, 2011. The device falls under product code OEW (Tracking, Soft Tissue, Intraoperative), a Class II device regulated under 21 CFR 882.4560. Pathfinder Therapeutics, Inc. has at least 3 other 510(k) clearances on record.
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.