Disposable And Reusable Ball And Loop Electrodes

No FDA recalls on record, checked 6 Oct 2026.

510(k) Number

K993777 ↗

FDA Product Code

HGI

Device Class

Class II

Regulation

21 CFR Part 884.4120

Advisory Committee

Obstetrics/Gynecology

FDA Decision

SESE Substantially Equivalent

• Acti-Flex Low, Medium, Rescare I, Rescare Ii.

  Class I

  FDA 510(k) K952470 Active Cleared 28 Nov 1995

• Acti-Flex Fluid Delivery System or Acti-Flex F D S

  Class II

  FDA 510(k) K001233 Active Cleared 13 Dec 2000

• Acti-Flex Arterial Extension Set

  Class I

  FDA 510(k) K954035 Active Cleared 25 Sep 1995

• One Wall Puncture Needle

  Class II

  FDA 510(k) K913267 Active Cleared 5 Jun 1992

• Acti-Flex Iv Administration Set

  Class II

  FDA 510(k) K001599 Active Cleared 18 Sep 2000

• R-Group International Coiled Low Pressure Extension Line

  Class II

  FDA 510(k) K940319 Active Cleared 10 Nov 1994

• What are the ball and loop electrodes used for in gynecologic procedures?

  The ball and loop electrodes are designed for excision of cervical or vaginal lesions and hemostasis (stopping bleeding) during gynecologic surgeries. They connect to an electrosurgical generator to cut tissue via electrical current and provide coagulation to seal blood vessels, ensuring precise and controlled tissue management.

• Are these electrodes available in disposable and reusable options?

  Yes, these electrodes come in both disposable and reusable configurations. The disposable versions are intended for single-use to ensure sterility and reduce cross-contamination risks, while the reusable types are designed for repeated use with proper cleaning and sterilization between procedures.

• What types of electrodes are included in this product?

  This product includes two types of electrodes: ball electrodes and loop electrodes. Ball electrodes are typically used for precise coagulation and cutting in smaller areas, while loop electrodes are ideal for excising larger lesions or tissue sections due to their looped shape.

• How should these electrodes be stored?

  Disposable electrodes should be stored in a clean, dry environment, protected from direct sunlight and extreme temperatures to maintain their integrity until use. Reusable electrodes must be stored in a sterile, sealed packaging or container when not in use, following manufacturer guidelines for cleaning and sterilization to prevent contamination.

• What regulatory approvals apply to these electrodes?

  These ball and loop electrodes have been cleared by the FDA through a 510(k) submission (K993777) and are classified as a Class II medical device under product code HGI. The clearance was determined to be Substantially Equivalent to a predicate device, ensuring compliance with U.S. regulatory standards for gynecologic electrocautery devices.