Browse hierarchy: [Neurology (NE)](/submissions/NE) → [Subpart F — Neurological Therapeutic Devices](/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices) → [21 CFR 882.5225](/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/882.5225) → HBP — Clip, Implanted Malleable

# HBP · Clip, Implanted Malleable

_Neurology · 21 CFR 882.5225 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/HBP

## Overview

- **Product Code:** HBP
- **Device Name:** Clip, Implanted Malleable
- **Regulation:** [21 CFR 882.5225](/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/882.5225)
- **Device Class:** 2
- **Review Panel:** [Neurology](/submissions/NE)
- **Implant:** yes

## Identification

An implanted malleable clip is a bent wire or staple that is forcibly closed with a special instrument to occlude an intracranial blood vessel or aneurysm (a balloonlike sac formed on a blood vessel), stop bleeding, or hold tissue or a mechanical device in place in a patient.

## Classification Rationale

Class II (performance standards).

## Recent Cleared Devices (0 of 0)

_No cleared devices on record._

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**Source:** [https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/HBP](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/HBP)

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