Skip to content

MGN Connecting Tube

by Mgn Medical Manufacturing, Inc.

510(k) K811541

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 NumberK811541 Date18 Jun 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  • Withdrawn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
BYY
Device Class
Class II
Regulation
21 CFR Part 880.6740
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 27 Sep 2026

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

A connecting tube is a device used to transfer fluids or gases between medical equipment or between equipment and a patient. It is designed to provide a secure, flexible pathway for aspirating or delivering substances in clinical settings.

The MGN Connecting Tube is supplied non-sterile and intended for reusable use after appropriate cleaning and sterilization by the user. It is powered by an external vacuum source and is regulated under FDA 510(k) clearance K811541, with product code BYY, and was determined substantially equivalent to a predicate device on June 18, 1981.

Other devices from Mgn Medical Manufacturing, Inc.

Questions

AI-generated answers, 27 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 MGN Connecting Tube used for?

    The MGN Connecting Tube is used to transfer fluids or gases between medical equipment or between equipment and a patient, providing a secure and flexible pathway for aspirating or delivering substances in clinical settings.

  • Is the MGN Connecting Tube sterile when supplied?

    The MGN Connecting Tube is supplied non-sterile and must be cleaned and sterilized by the user before each reuse to ensure it is safe for clinical use.

  • Can the MGN Connecting Tube be reused?

    Yes, the MGN Connecting Tube is intended for reusable use after appropriate cleaning and sterilization by the user, as it is designed for multiple cycles of use following proper reprocessing.

  • What powers the MGN Connecting Tube during operation?

    The MGN Connecting Tube is powered by an external vacuum source, which provides the necessary suction or pressure to move fluids or gases through the tube during clinical use.

  • What regulatory pathway was used for the MGN Connecting Tube?

    The MGN Connecting Tube received FDA 510(k) clearance under K811541, with product code BYY, and was determined substantially equivalent to a predicate device on June 18, 1981.