Arthroscopy Infusion Sys..Valve

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

510(k) Number

K831218 ↗

FDA Product Code

HRX

Device Class

Class II

Regulation

21 CFR Part 888.1100

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Acufex Metal Acl Cannula

  Class II

  FDA 510(k) K932718 Active Cleared 21 Mar 1994

• Acufex Endofix Absorbable Interference Screw

  Class II

  FDA 510(k) K954246 Active Cleared 15 Feb 1996

• Acufex Arthroscopic Shoulder Guide System

  Class II

  FDA 510(k) K940481 Active Cleared 6 May 1994

• Acufex Arthroscopic Shaver

  Class I

  FDA 510(k) K844130 Active Cleared 21 Mar 1985

• Acufex Endobutton System

  Class II

  FDA 510(k) K933948 Active Cleared 21 Jul 1994

• Flouroshield Radiation Reduction Glove

  Class I

  FDA 510(k) K893093 Active Cleared 13 Feb 1990

See all devices from Acufex Microsurgical, Inc. →

• What is the Arthroscopy Infusion Sys..Valve used for?

  The Arthroscopy Infusion Sys..Valve is designed to regulate fluid flow during arthroscopic procedures, maintaining optimal visualization and working conditions within the joint space during joint examinations or surgeries.

• Is the Arthroscopy Infusion Sys..Valve single-use or reusable?

  The device can be supplied for either single-use or reusable applications as specified by the manufacturer, Acufex Microsurgical, Inc., depending on the specific product configuration and intended use.

• What sizes and models of the Arthroscopy Infusion Sys..Valve are available?

  The Arthroscopy Infusion Sys..Valve is available in various sizes to accommodate different clinical needs, though specific size details would need to be confirmed with the manufacturer's product documentation.

• What is the regulatory status of the Arthroscopy Infusion Sys..Valve?

  The device has received FDA 510(k) clearance with product code HRX and authorization number K831218, making it substantially equivalent to predicate devices for its intended use in arthroscopic procedures.