OEW — Tracking, Soft Tissue, Intraoperative Class II
FDA product code OEW covers "Tracking, Soft Tissue, Intraoperative", a Class II medical device regulated under 21 CFR 882.4560. Submissions are reviewed by the Neurology panel. At least 4 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- OEW
- Device Class
- Class II
- Regulation Number
- 882.4560
- Submission Type
- Review Panel
- SU
- Medical Specialty
- Neurology
- Implant
- No
Definition
For open liver surgical procedures where image-guidance may be appropriate and where the patient can tolerate long apneic periods under general anesthesia.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K143024 | Cascination | CAS-One Liver | Apr 28, 2015 |
| K101979 | Pathfinder Therapeutics | EXPLORER LIVER (PASSIVE TRACKING) | Feb 9, 2011 |
| K093494 | Pathfinder Therapeutics | LINASYS IMAGE-GUIDED LIVER SURGERY SYSTEM | Mar 30, 2010 |
| K071063 | Pathfinder Therapeutics | LINASYS | Dec 20, 2007 |