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Airway Support System / Airport

by Abeon Medical Corporation

510(k) K131506

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 NumberK131506 Date6 Mar 2014ClearedStatusActive

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  • Withdrawn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
CCK
Device Class
Class II
Regulation
21 CFR Part 868.1400
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 21 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 Airway Support System / Airport is a device designed to provide airway support during medical procedures. It is categorized under product code CCK and is intended for use in anesthesiology settings.

This device is supplied by Abeon Medical Corporation and has received FDA 510K clearance as substantially equivalent. The system is available in various sizes and is designed for single-use or reusable applications, depending on the specific model. It should be stored according to the manufacturer's instructions and is MRI safe as per regulatory specifications.

Other devices from Abeon Medical Corporation

Questions

AI-generated answers, 21 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 Airway Support System / Airport used for?

    The Airway Support System / Airport is designed to provide airway support during medical procedures, specifically in anesthesiology settings. It helps maintain patient airways during various medical interventions.

  • Is the Airway Support System / Airport single-use or reusable?

    The system is available in various sizes and is designed for either single-use or reusable applications depending on the specific model selected. Users should follow manufacturer instructions for the particular model they are using.

  • What regulatory approvals does the Airway Support System / Airport have?

    The Airway Support System / Airport has received FDA 510K clearance as substantially equivalent. It is categorized under product code CCK and is MRI safe as per regulatory specifications.

  • How should the Airway Support System / Airport be stored?

    The device should be stored according to the manufacturer's instructions. Proper storage conditions help maintain the device's integrity and functionality until use.