← Product Code [HBE](/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HBE) · K930229

# CLINICAL NEURO SYSTEMS CRANIAL DRILL (K930229)

_Clinical Neuro Systems, LLC · HBE · Mar 16, 1993 · Neurology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HBE/K930229

## Device Facts

- **Applicant:** Clinical Neuro Systems, LLC
- **Product Code:** [HBE](/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HBE.md)
- **Decision Date:** Mar 16, 1993
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 882.4310
- **Device Class:** Class 2
- **Review Panel:** Neurology

## Regulatory Identification

Powered simple cranial drills, burrs, trephines, and their accessories are bone cutting and drilling instruments used on a patient's skull. The instruments are used with a power source but do not have a clutch mechanism to disengage the tip after penetrating the skull.

---

**Source:** [https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HBE/K930229](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HBE/K930229)

**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