Acufex Adjustable-Length Cannula

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

510(k) Number

K934181 ↗

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 Acufex Adjustable-Length Cannula used for?

  The Acufex Adjustable-Length Cannula is designed for orthopedic surgical procedures, providing controlled passage of instruments or fluids within the surgical field. Its adjustable length feature allows for precise manipulation and positioning, accommodating varying anatomical requirements during minimally invasive techniques. This versatility makes it particularly useful in procedures where flexibility in instrument access is critical.

• Is the Acufex Adjustable-Length Cannula single-use or reusable?

  The Acufex Adjustable-Length Cannula is classified as a reusable device. This classification is inferred from its regulatory submission history and product code (HRX), which typically aligns with instruments intended for repeated use under proper sterilization protocols. Always follow manufacturer guidelines and standard operating room protocols for sterilization and handling to ensure safe reuse.

• What regulatory approval does the Acufex Adjustable-Length Cannula have?

  The Acufex Adjustable-Length Cannula holds FDA 510(k) clearance under the reference number K934181, granted on March 23, 1994. This clearance was based on a determination of substantial equivalence to a predicate device, following review by the Orthopedic Advisory Committee. The device is intended for professional surgical use only and adheres to standard regulatory requirements.

• Does the Acufex Adjustable-Length Cannula come with specific sterility or MRI safety information?

  The available data does not provide explicit details regarding the sterility status or MRI safety of the Acufex Adjustable-Length Cannula. For clinical use, it is essential to follow standard operating room protocols for preparation, sterilization, and handling. If MRI compatibility is required, additional manufacturer documentation or testing should be consulted to ensure safe use in magnetic environments.

• How is the Acufex Adjustable-Length Cannula supplied, and what should be considered during storage?

  The Acufex Adjustable-Length Cannula is supplied as a reusable surgical instrument, intended for professional use in orthopedic procedures. Proper storage involves maintaining the device in a clean, dry environment to prevent contamination or damage. Before each use, it must undergo appropriate sterilization processes as outlined by the manufacturer and adhering to standard surgical protocols. Ensure the device is stored in its original packaging or a designated sterile container when not in use.