← Product Code [HAW](/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HAW) · K963173

# STEALTHSTATION SYSTEM (K963173)

_Surgical Navigation Technologies, Inc. · HAW · Oct 25, 1996 · Neurology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HAW/K963173

## Device Facts

- **Applicant:** Surgical Navigation Technologies, Inc.
- **Product Code:** [HAW](/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HAW.md)
- **Decision Date:** Oct 25, 1996
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 882.4560
- **Device Class:** Class 2
- **Review Panel:** Neurology

## Device Story

StealthStation™ System; surgical navigation device. Submission adds STERRAD® Sterilization System as validated reprocessing option for specific system components. Validation performed by independent lab per AAMI TIR No. 12-1994 guidelines for reusable medical devices.

## Clinical Evidence

Bench testing only; validation of sterilization process performed by independent laboratory in accordance with AAMI TIR No. 12-1994.

## Technological Characteristics

Reusable medical device components; sterilization via STERRAD® Sterilization System; validation per AAMI TIR No. 12-1994.

## Regulatory 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.

## Reference Devices

- StealthStation™ System (previous 510(k) submission)

## Submission Summary (Full Text)

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K963173

OCT 25 1996

510(k)

Summary of Safety and Effectiveness

StealthStation™ System Sterilization

I. Company: Surgical Navigation Technologies
530 Compton St.
Broomfield, CO 80020
(303) 439-9709

II. Product Name: StealthStation™ System

III. This submission describes the addition of the STERRAD®* Sterilization System as a sterilization option for certain components of the StealthStation™ System which was cleared in a previous 510(k) submission. This sterilization option was validated by an independent laboratory in accordance with the AAMI TIR No. 12-1994, Designing, Testing and Labeling Reusable Medical Devices for Reprocessing in Health Care Facilities: A Guide for Device Manufacturers.

*STERRAD is a registered trademark of Advanced Sterilization Products, a Division of Johnson and Johnson Medical, Inc.

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**Source:** [https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HAW/K963173](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HAW/K963173)

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