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Teflon-Coated Hypodermic Needles/Regional Block

by Professional Instruments Co.

510(k) K864830

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK864830 Date12 Jan 1987ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 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  • Withdrawn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
BXN
Device Class
Class II
Regulation
21 CFR Part 868.2775
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

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

Teflon-Coated Hypodermic Needles/Regional Block is a device classified as a Stimulator, Nerve, Battery-Powered, used in the field of anesthesiology. It is designed for regional nerve stimulation procedures.

The device is supplied by Professional Instruments Co. and has received FDA 510(k) clearance under K864830 with a decision of substantially equivalent (SESE). It is intended for use in clinical settings requiring nerve stimulation, as indicated by its product code BXN and regulatory classification under 868.2775.

Other devices from Professional Instruments Co.

Questions

AI-generated answers, 1 Oct 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 TEFLON-COATED HYPODERMIC NEEDLES/REGIONAL BLOCK used for?

    This device is designed for regional nerve stimulation procedures in anesthesiology, functioning as a battery-powered nerve stimulator to assist in locating nerves during regional block administration.

  • How is the TEFLON-COATED HYPODERMIC NEEDLES/REGIONAL BLOCK supplied and by whom?

    The device is supplied by Professional Instruments Co., as indicated in the manufacturer field, and is provided as a teflon-coated hypodermic needle configured for regional block nerve stimulation.

  • Is the TEFLON-COATED HYPODERMIC NEEDLES/REGIONAL BLOCK intended for single-use or reuse?

    While the device data does not explicitly state whether it is single-use or reusable, its classification as a hypodermic needle with a teflon coating and use in invasive nerve stimulation procedures strongly suggests it is intended for single-use to maintain sterility and prevent cross-contamination.