Grieshaber Air System/Pressure Ophthalmic Irrigant

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

510(k) Number

K864056 ↗

FDA Product Code

HQC

Device Class

Class II

Regulation

21 CFR Part 886.4670

Advisory Committee

Ophthalmic

FDA Decision

SESE Substantially Equivalent

• The Grieshaber Axial Cutter

  Class II

  FDA 510(k) K950056 Active Cleared 5 May 1995

• Green-Line Bipolar Coagulation Unit

  Class II

  FDA 510(k) K860479 Active Cleared 1 May 1986

• Grieshaber Global Control Tubing Set

  Class II

  FDA 510(k) K863444 Active Cleared 31 Oct 1986

• Zzipp Instant Bovie Cleaner

  Class II

  FDA 510(k) K900714 Active Cleared 27 Mar 1990

• The Grieshaber Syst/Ai Tubing Set and Cartridge

  Class II

  FDA 510(k) K930842 Active Cleared 3 May 1994

• Grieshaber Two Function Manipulator

  Class I

  FDA 510(k) K914585 Active Cleared 3 Jan 1992

See all devices from Grieshaber & Co. →

• What is the primary function of the Grieshaber Air System?

  The Grieshaber Air System is designed for use in ophthalmic procedures to provide controlled irrigation and pressure management within the eye.

• How is this device classified for regulatory purposes?

  This device is classified as a Class 2 medical device under the ophthalmic specialty, specifically categorized as a phacofragmentation unit.

• What is the regulatory status of this device?

  The Grieshaber Air System has received FDA 510(k) clearance under the number K864056, confirming it has been found substantially equivalent to other legally marketed devices.