Browse hierarchy: [Anesthesiology (AN)](/submissions/AN) → [Subpart F — Therapeutic Devices](/submissions/AN/subpart-f%E2%80%94therapeutic-devices) → [21 CFR 868.5150](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/868.5150) → MIA — Needle, Spinal, Short Term

# MIA · Needle, Spinal, Short Term

_Anesthesiology · 21 CFR 868.5150 · Class 2_

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

## Overview

- **Product Code:** MIA
- **Device Name:** Needle, Spinal, Short Term
- **Regulation:** [21 CFR 868.5150](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/868.5150)
- **Device Class:** 2
- **Review Panel:** [Anesthesiology](/submissions/AN)
- **3rd-party reviewable:** yes

## Identification

An anesthesia conduction needle is a device used to inject local anesthetics into a patient to provide regional anesthesia.

## Classification Rationale

Class II (performance standards).

## Recent Cleared Devices (10 of 10)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K172800](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/MIA/K172800.md) | Portex® Lancet Point Spinal Needles with NRFit™ connectors, Portex® Pencil Point Spinal Needles with NRFit™ connectors | Smiths Medical Asd, Inc. | Jun 14, 2018 | SESE |
| [K051860](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/MIA/K051860.md) | FLEXIBLE INTRODUCER CANNULA, MODEL 135-1837 | Epimed International, Inc. | Aug 22, 2005 | SESE |
| [K983858](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/MIA/K983858.md) | SPINAL ANESTHESIA NEEDLES AND INTRODUCER NEEDLES | Sims Portex, Inc. | Jan 29, 1999 | SESE |
| [K982269](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/MIA/K982269.md) | CLEAR HUB SPINAL NEEDLE 14GA, 16GA, 17GA, 18GA, 20GA, 21GA, 22GA, 25GA, 26GA AND 27GA | Allegiance Healthcare Corp. | Jul 23, 1998 | SESE |
| [K971645](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/MIA/K971645.md) | REGANES SPINAL NEEDLE (VARIOUS) | Avid N.I.T., Inc. | Aug 1, 1997 | SESE |
| [K970997](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/MIA/K970997.md) | NEO-CARE LUMBER PUNCTURE KIT | Klein-Baker Medical, Inc. | May 22, 1997 | SESE |
| [K961324](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/MIA/K961324.md) | GLOBAL MEDICAL PRODUCTS SPINAL,CONICAL TIP (SPROTTLE STYLE), WHITACRE STYLE NEEDLES | Global Medical Prods, Inc. | Jul 2, 1996 | SESE |
| [K960405](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/MIA/K960405.md) | SPINAL NEEDLE | Promex, Inc. | Feb 28, 1996 | SESE |
| [K942442](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/MIA/K942442.md) | ACUFEX T-FIX DELIVERY SYSTEM | Acufex Microsurgical, Inc. | Dec 5, 1994 | SESE |
| [K904380](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/MIA/K904380.md) | SPINAL CORD ACCESS EPIDURAL INTRODUCER SYSTEM | Custom Medical Concepts, Inc. | Apr 8, 1993 | SESK |

## Top Applicants

- Acufex Microsurgical, Inc. — 1 clearance
- Allegiance Healthcare Corp. — 1 clearance
- Avid N.I.T., Inc. — 1 clearance
- Custom Medical Concepts, Inc. — 1 clearance
- Epimed International, Inc. — 1 clearance

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

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