← Product Code [HAE](/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HAE) · K943583

# KERRISON RONGEURS (K943583)

_Enterprise Medical Corp. · HAE · Feb 21, 1995 · Neurology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HAE/K943583

## Device Facts

- **Applicant:** Enterprise Medical Corp.
- **Product Code:** [HAE](/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HAE.md)
- **Decision Date:** Feb 21, 1995
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 882.4840
- **Device Class:** Class 2
- **Review Panel:** Neurology

## Regulatory Identification

A manual rongeur is a manually operated instrument used for cutting or biting bone during surgery involving the skull or spinal column.

---

**Source:** [https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HAE/K943583](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HAE/K943583)

**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