Browse hierarchy: [Neurology (NE)](/submissions/NE) → [Subpart E — Neurological Surgical Devices](/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices) → [21 CFR 882.4560](/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/882.4560) → OEW — Tracking, Soft Tissue, Intraoperative

# OEW · Tracking, Soft Tissue, Intraoperative

_Neurology · 21 CFR 882.4560 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/OEW

## Overview

- **Product Code:** OEW
- **Device Name:** Tracking, Soft Tissue, Intraoperative
- **Regulation:** [21 CFR 882.4560](/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/882.4560)
- **Device Class:** 2
- **Review Panel:** [Neurology](/submissions/NE)
- **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](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/OEW/K143024.md) | CAS-One Liver | Cascination AG | Apr 28, 2015 | SESE |
| [K101979](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/OEW/K101979.md) | EXPLORER LIVER (PASSIVE TRACKING) | Pathfinder Therapeutics, Inc. | Feb 9, 2011 | SESE |
| [K093494](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/OEW/K093494.md) | LINASYS IMAGE-GUIDED LIVER SURGERY SYSTEM | Pathfinder Therapeutics, Inc. | Mar 30, 2010 | SESE |
| [K071063](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/OEW/K071063.md) | LINASYS | Pathfinder Therapeutics, Inc. | Dec 20, 2007 | SESE |

## Top Applicants

- Pathfinder Therapeutics, Inc. — 3 clearances
- Cascination AG — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/OEW](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/OEW)

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