Browse hierarchy: [General Hospital (HO)](/submissions/HO) → [Subpart F — General Hospital and Personal Use Therapeutic Devices](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices) → [21 CFR 880.5570](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/880.5570) → MHC — Needle, Interosseous

# MHC · Needle, Interosseous

_General Hospital · 21 CFR 880.5570 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/MHC

## Overview

- **Product Code:** MHC
- **Device Name:** Needle, Interosseous
- **Regulation:** [21 CFR 880.5570](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/880.5570)
- **Device Class:** 2
- **Review Panel:** [General Hospital](/submissions/HO)
- **Implant:** yes

## Identification

A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.

## Classification Rationale

Class II (performance standards).

## Recent Cleared Devices (2 of 2)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K223198](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/MHC/K223198.md) | BD Intraosseous Vascular Access System EMS Powered Driver (D001003) | Bard Access Systems | Nov 10, 2022 | SESE |
| [K203193](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/MHC/K203193.md) | BD Intraosseous Infusion System | Bard Access Systems, Inc(Bas)[Wholly-Owned Subsidiary of Bd] | Mar 4, 2021 | SESE |

## Top Applicants

- Bard Access Systems — 1 clearance
- Bard Access Systems, Inc(Bas)[Wholly-Owned Subsidiary of Bd] — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/MHC](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/MHC)

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