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Plexufix Brachial Plexus Anesth Needle

by Burron Medical Products, Inc.

510(k) K813165

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK813165 Date3 Dec 1981ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
BSP
Device Class
Class II
Regulation
21 CFR Part 868.5150
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 22 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Plexufix Brachial Plexus Anesth Needle is a conduction anesthetic needle used for brachial plexus block, a regional anesthesia technique. It is designed to administer anesthetic to the brachial plexus, which is formed from the nerve roots of C5, C6, C7, C8, and T1. The device is used in anesthesiology, specifically for procedures involving the upper extremity.

The Plexufix Brachial Plexus Anesth Needle is supplied by Burron Medical Products, Inc. and has been granted FDA 510K clearance (K813165). The device is classified as a class 2 device with the regulation number 868.5150. It is intended for use in medical settings, such as hospitals or clinics, and is used by medical professionals, including anesthesiologists.

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Questions

AI-generated answers, 22 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the intended use of the Plexufix Brachial Plexus Anesth Needle?

    The Plexufix Brachial Plexus Anesth Needle is intended for use in medical settings, such as hospitals or clinics, for procedures involving the upper extremity, specifically for brachial plexus block, a regional anesthesia technique.

  • Is the Plexufix Brachial Plexus Anesth Needle supplied sterile?

    The device data does not explicitly state that the needle is supplied sterile, but it is intended for use in medical settings and should be handled and used according to proper medical protocols.

  • What is the regulatory classification of the Plexufix Brachial Plexus Anesth Needle?

    The device is classified as a class 2 device with the regulation number 868.5150, and has been granted FDA 510K clearance (K813165).