Electrosurgical Cutting & Coagulation Device/Acces

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

510(k) Number

K854231 ↗

FDA Product Code

GEI

Device Class

Class II

Regulation

21 CFR Part 878.4400

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Biosign

  Class II

  FDA 510(k) K872867 Active Cleared 6 Jul 1988

• Glyco-Sep/Alc Test Kit for Separat of Hemoglobin

  Class II

  FDA 510(k) K852986 Active Cleared 19 Aug 1985

• Bovie Ultrasonic Surgical Aspirator, Model ME2000

  Unclassified

  FDA 510(k) K880166 Active Cleared 18 Feb 1988

• Disposable Arthroscopy Cannula Set

  Class I

  FDA 510(k) K813000 Active Cleared 22 Jan 1982

• Bovie X-10 Electrosurgical Generator(Unit)

  Class II

  FDA 510(k) K844565 Active Cleared 21 Feb 1985

• Steri-Grip

  Not classified

  FDA 510(k) K853507 Active Cleared 5 Sep 1985

See all devices from Clinical Technology Corp. →

• What is the Clinical Technology Corp. electrosurgical cutting and coagulation device used for?

  This device delivers high-frequency electrical current to precisely cut and seal soft tissues during surgical procedures. It is designed to minimize postoperative bleeding and support faster wound healing, making it ideal for general and plastic surgery applications.

• Is the Clinical Technology Corp. electrosurgical device single-use or reusable?

  The device is intended for reuse in controlled clinical settings like operating rooms. It must be sterilized prior to each use following standard medical sterilization protocols, as it is not sterile upon packaging.

• What type of sterilization does the Clinical Technology Corp. electrosurgical device require?

  The device requires sterilization before use, adhering to standard medical sterilization protocols. Since it is reusable, it must be properly cleaned and sterilized between procedures to ensure safety and functionality.

• Does the Clinical Technology Corp. electrosurgical cutting and coagulation device have an MRI safety classification?

  The available data does not specify an MRI safety classification for this device. If MRI compatibility is a concern, additional information should be consulted directly from the manufacturer.

• What regulatory pathway was used for the FDA clearance of this device?

  The device received FDA clearance under the Traditional 510(k) review pathway, with a decision of Substantially Equivalent (SESE). It falls under the FDA’s regulation 878.4400 and is classified as FDA Class II.