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Mediblend Medical Laser Gas Mixtures

by Linde Div. Union Carbide Corp.

510(k) K882208

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 NumberK882208 Date3 Aug 1988ClearedStatusActive

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  • Withdrawn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)

Full name
Mediblend (Tm) Medical Laser Gas Mixtures
510(k) Number
FDA Product Code
GEX
Device Class
Class II
Regulation
21 CFR Part 878.4810
Advisory Committee
General, Plastic Surgery
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.

Mediblend Medical Laser Gas Mixtures are specialized gas compositions designed for use with laser technology. These mixtures are intended to support the operation of laser systems in surgical applications.

This device is supplied by Linde Div. Union Carbide Corp. and has received FDA 510(k) clearance under the identifier K882208. It is classified under product code GEX for use within general and plastic surgery settings.

Other devices from Linde Div. Union Carbide Corp.

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 Mediblend Medical Laser Gas Mixtures?

    These gas mixtures are specifically formulated to support the operation of laser systems used during surgical procedures. They are designed to provide the necessary gas composition required for the functional performance of medical laser equipment.

  • What is the regulatory status of this device?

    Mediblend Medical Laser Gas Mixtures have received FDA 510(k) clearance under the identifier K882208. This indicates that the device has been determined to be substantially equivalent to a legally marketed predicate device.

  • In which clinical settings are these gas mixtures used?

    The device is classified under product code GEX, which is designated for use within general and plastic surgery settings. These mixtures are intended to facilitate the operation of laser technology utilized by clinicians in these specific surgical fields.