OEW · Tracking, Soft Tissue, Intraoperative
Neurology · 21 CFR 882.4560 · Class 2
Overview
| Product Code | OEW |
|---|---|
| Device Name | Tracking, Soft Tissue, Intraoperative |
| Regulation | 21 CFR 882.4560 |
| Device Class | Class 2 |
| Review Panel | Neurology |
| Life-Sustaining | Yes |
Identification
A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (4 of 4)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K143024 | CAS-One Liver | Cascination AG | Apr 28, 2015 | SESE |
| K101979 | EXPLORER LIVER (PASSIVE TRACKING) | Pathfinder Therapeutics, Inc. | Feb 9, 2011 | SESE |
| K093494 | LINASYS IMAGE-GUIDED LIVER SURGERY SYSTEM | Pathfinder Therapeutics, Inc. | Mar 30, 2010 | SESE |
| K071063 | LINASYS | Pathfinder Therapeutics, Inc. | Dec 20, 2007 | SESE |
Top Applicants
- Pathfinder Therapeutics, Inc. — 3 clearances
- Cascination AG — 1 clearance
