Grieshaber Global Control Tubing Set

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

510(k) Number

K863444 ↗

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 Air System/Pressure Ophthalmic Irrigant

  Class II

  FDA 510(k) K864056 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 Grieshaber Global Control Tubing Set used for?

  It is used in phacofragmentation procedures within ophthalmic surgery to control fluid dynamics during cataract surgery involving ultrasonic fragmentation of the lens.

• Is the Grieshaber Global Control Tubing Set sterile and single-use?

  Yes, it is supplied as a single-use, sterile tubing set intended for use in ophthalmic surgical settings, ensuring sterility and eliminating reprocessing risks.

• What regulatory clearance does the Grieshaber Global Control Tubing Set have?

  It has received FDA 510(k) clearance under K863444 and is classified as a Class II medical device under regulation number 886.4670.