Browse hierarchy: [Neurology (NE)](/submissions/NE) → [Subpart E — Neurological Surgical Devices](/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices) → [21 CFR 882.4750](/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/882.4750) → GXJ — Punch, Skull

# GXJ · Punch, Skull

_Neurology · 21 CFR 882.4750 · Class 1_

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

## Overview

- **Product Code:** GXJ
- **Device Name:** Punch, Skull
- **Regulation:** [21 CFR 882.4750](/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/882.4750)
- **Device Class:** 1
- **Review Panel:** [Neurology](/submissions/NE)

## Identification

A skull punch is a device used to punch holes through a patient's skull to allow fixation of cranioplasty plates or bone flaps by wire or other means.

## Classification Rationale

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 882.9. This exemption does not apply to powered compound cranial drills, burrs, trephines, and their accessories classified under § 882.4305.

## Recent Cleared Devices (0 of 0)

_No cleared devices on record._

---

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

**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