Endocare Electrosurgical Handpiece

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K952698 ↗

FDA Product Code

GEI

Device Class

Class II

Regulation

21 CFR Part 878.4400

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Endocare Monopolar Electrodes (Modification)

  Class II

  FDA 510(k) K954321 Active Cleared 13 Oct 1995

• Endocare Prolase I Advanced Laser Delivery System

  Class II

  FDA 510(k) K945054 Active Cleared 28 Nov 1994

• Endocare Monopolar Electrodes

  Class II

  FDA 510(k) K952587 Active Cleared 17 Jul 1995

• Endocare Cryotherapy System

  Class II

  FDA 510(k) K942299 Active Cleared 19 Jan 1995

• Cytocare Laser Catheter for Urology

  Class II

  FDA 510(k) K921708 Active Cleared 1 Oct 1992

• Cytocare Diode Laser System

  Class II

  FDA 510(k) K934211 Active Cleared 17 May 1994

• Is the Endocare Electrosurgical Handpiece intended for single-use or reusable in the operating room? Why does this matter?

  The Endocare Electrosurgical Handpiece is designed as a reusable device, meaning it is meant to be sterilized and reused multiple times in controlled surgical settings. This matters because reusable instruments reduce waste and costs compared to single-use devices, but they require proper cleaning, sterilization, and maintenance protocols to ensure safety and functionality between uses.

• What types of surgical procedures is this handpiece primarily used for, and why is it considered suitable for those applications?

  The Endocare Electrosurgical Handpiece is primarily used in general and plastic surgery procedures. It is designed for tissue dissection, coagulation, and fulguration, which means it provides precise control of electrical current to cut, seal blood vessels, and cauterize tissue—key functions in surgeries requiring careful tissue manipulation and hemostasis.

• How is the device supplied, and what should clinicians know about its maintenance or preparation before use?

  The device is supplied as a reusable electrosurgical handpiece, meaning it comes ready for surgical use but must be cleaned, inspected, and sterilized before each procedure. Since it is not single-use, clinicians must follow manufacturer guidelines for proper maintenance, including disassembly (if applicable), cleaning with appropriate detergents, and sterilization (e.g., autoclave or chemical sterilization) to prevent cross-contamination and ensure reliable performance.

• Does the Endocare Electrosurgical Handpiece come in different sizes or models, and if so, how might that affect its use?

  The provided data does not specify variations in sizes or models for the Endocare Electrosurgical Handpiece. Typically, electrosurgical handpieces may vary by grip design, cable length, or attachment options (e.g., different electrode tips), but without explicit details here, clinicians should confirm with Cytocare whether their specific surgical needs (e.g., ergonomics or procedural requirements) align with the standard design.

• Is there any information about whether this device is safe for use in MRI environments, and why might that be important?

  The available data does not provide any explicit information regarding MRI safety for the Endocare Electrosurgical Handpiece. This is important because electrosurgical devices can interfere with MRI equipment due to electromagnetic interference or metallic components, potentially causing hazards in MRI suites. Clinicians should verify compatibility with their facility’s MRI protocols or consult the manufacturer for guidance before use in such environments.