Endius Bipolar Sheath

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

Full name

Modification to:endius Bipolar Sheath

510(k) Number

K012488 ↗

FDA Product Code

GEI

Device Class

Class II

Regulation

21 CFR Part 878.4400

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Endius Flextip Blade

  Class II

  FDA 510(k) K022578 Active Cleared 23 Aug 2002

• Endius Minit Posterior Cervical and Upper Thoracic Fixation System

  Class II

  FDA 510(k) K060683 Active Cleared 18 Apr 2006

• Endius Spinal Fixation System

  Class II

  FDA 510(k) K014090 Active Cleared 11 Mar 2002

• Endius Title 2 Polyaxial Spinal System

  Class II

  FDA 510(k) K070367 Active Cleared 12 Apr 2007

• Endius Endoscopic Access System

  Class II

  FDA 510(k) K002437 Active Cleared 2 Oct 2000

• Endius Spine Endoscope

  Class II

  FDA 510(k) K982819 Active Cleared 27 Jan 1999

See all devices from Endius, Inc. →

• What types of surgical procedures is the Endius Bipolar Sheath designed to assist with, and how does it work during these procedures?

  The Endius Bipolar Sheath is designed to assist in general and plastic surgery procedures that involve automated tissue removal or coagulation. It fits over an automated tissue removal blade and delivers controlled electrosurgical energy during excision or coagulation, ensuring precise and efficient tissue management. It works by interfacing with Valley Lab Force 2, FX, or EZ electrosurgical generators via a Bipolar Sheath Adapter, which reduces the generator voltage from 800V to 100V for safer energy delivery.

• Is the Endius Bipolar Sheath intended for single-use or reusable applications, and how should it be maintained?

  The Endius Bipolar Sheath is supplied as a reusable medical instrument. Since it is not specified as sterile or MRI-safe, proper cleaning, sterilization, and maintenance protocols must be followed per facility guidelines to ensure safe reuse. Always refer to manufacturer instructions for cleaning and reprocessing to maintain performance and prevent contamination.

• Which electrosurgical generators are compatible with the Endius Bipolar Sheath, and what role does the adapter play in its function?

  The Endius Bipolar Sheath is compatible with Valley Lab Force 2, FX, or EZ electrosurgical generators. The Bipolar Sheath Adapter is essential for safe operation, as it reduces the generator voltage from 800V to 100V, ensuring controlled energy delivery during procedures. This adapter acts as an intermediary to optimize performance while minimizing risk.

• What is the regulatory pathway for the Endius Bipolar Sheath, and what classification does it fall under?

  The Endius Bipolar Sheath follows an FDA 510(k) clearance pathway, specifically under K012488, and is classified as Substantially Equivalent (SESE). It is regulated under FDA Class II standards (Regulation Number: 878.4400) and is intended for general and plastic surgery applications. The device was reviewed by the Surgical Devices Panel (SU) and received clearance on August 30, 2001.