← Product Code [HAW](/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HAW) · K946033

# LEIBINGER STEREOPLAN PLUS STEROTACTIC TREATMENT PLAN ING SOFTWARE PACKAGE (K946033)

_Leibinger GmbH · HAW · Sep 1, 1995 · Neurology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HAW/K946033

## Device Facts

- **Applicant:** Leibinger GmbH
- **Product Code:** [HAW](/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HAW.md)
- **Decision Date:** Sep 1, 1995
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 882.4560
- **Device Class:** Class 2
- **Review Panel:** Neurology

## 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.

---

**Source:** [https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HAW/K946033](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HAW/K946033)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com