Acufex Meniscal Rasps

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

510(k) Number

K932460 ↗

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 are the Acufex Meniscal Rasps used for?

  The Acufex Meniscal Rasps are precision surgical instruments designed to assist in the debridement and shaping of the meniscus during arthroscopic knee surgery. They help orthopedic surgeons smooth out the meniscal surface, facilitating better healing and reducing the risk of further injury.

• What styles and catalog numbers are available for the Acufex Meniscal Rasps?

  The Acufex Meniscal Rasps are available in two styles: 90° Rasp (Catalog #014550) and 45° Rasp (Catalog #014549). These styles are designed to freshen the edge of the meniscal tear prior to repair and are not for use with plastic cannulae.

• What is the regulatory status of the Acufex Meniscal Rasps?

  The Acufex Meniscal Rasps received FDA 510(k) clearance on March 22, 1994, with product code HRX. They were determined to be substantially equivalent through the traditional clearance process and reviewed by the Orthopedic advisory committee.

• How should the Acufex Meniscal Rasps be stored?

  The device data does not specify storage requirements for the Acufex Meniscal Rasps. For proper storage and handling, users should refer to the manufacturer's instructions provided with the product or contact Acufex Microsurgical, Inc. directly.