Browse hierarchy: [Neurology (NE)](/submissions/NE) → [Subpart E — Neurological Surgical Devices](/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices) → [21 CFR 882.4150](/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/882.4150) → HBO — Clip, Scalp

# HBO · Clip, Scalp

_Neurology · 21 CFR 882.4150 · Class 2_

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

## Overview

- **Product Code:** HBO
- **Device Name:** Clip, Scalp
- **Regulation:** [21 CFR 882.4150](/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/882.4150)
- **Device Class:** 2
- **Review Panel:** [Neurology](/submissions/NE)
- **3rd-party reviewable:** yes

## Identification

A scalp clip is a plastic or metal clip used to stop bleeding during surgery on the scalp.

## Classification Rationale

Class II (performance standards).

## Recent Cleared Devices (10 of 10)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K050044](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HBO/K050044.md) | MEDTRONIC CLIP GUN KIT | Medtronic Neurosurgery | Feb 7, 2005 | SESE |
| [K033660](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HBO/K033660.md) | STORZ RANEY SCALP CLIP, MODEL 1-20-004-05 | Rudolf Storz GmbH | Jan 7, 2004 | SESE |
| [K012219](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HBO/K012219.md) | SCALPFIX CLIP SYSTEM | Aesculap, Inc. | Jul 31, 2001 | SESE |
| [K944311](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HBO/K944311.md) | ACRA-CUT | Acra Cut, Inc. | Nov 18, 1994 | SESE |
| [K905433](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HBO/K905433.md) | CODMAN DISPOSABLE SCALP CLIP APPLIER | Codman & Shurtleff, Inc. | Feb 21, 1991 | SESE |
| [K896723](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HBO/K896723.md) | CLIP GUN WITH RANEY TYPE SCALP CLIPS | Omni Medical Designs | Mar 23, 1990 | SESE |
| [K894778](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HBO/K894778.md) | CODMAN RF-12 DISPOSABLE SCALP CLIP APPLIER | Codman & Shurtleff, Inc. | Dec 6, 1989 | SESE |
| [K890443](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HBO/K890443.md) | CASPAR SCALP CLIP, APPLIER | Aesculap Instruments Corp. | Jun 15, 1989 | SESE |
| [K883963](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HBO/K883963.md) | RANEY AND LEROY-RANEY SCALP CLIP | New England Surgical Instrument Corp. | Oct 7, 1988 | SESE |
| [K881265](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HBO/K881265.md) | RANEY CLIPS | Zimmer, Inc. | May 31, 1988 | SESE |

## Top Applicants

- Codman & Shurtleff, Inc. — 2 clearances
- Acra Cut, Inc. — 1 clearance
- Aesculap Instruments Corp. — 1 clearance
- Aesculap, Inc. — 1 clearance
- Medtronic Neurosurgery — 1 clearance

---

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

**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