Single Use Tungsten Wire Lee Loop Electrode

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K925333 ↗

FDA Product Code

HGI

Device Class

Class II

Regulation

21 CFR Part 884.4120

Advisory Committee

Obstetrics/Gynecology

FDA Decision

SESE Substantially Equivalent

• Electrosurgical Unit with Accessories

  Class II

  FDA 510(k) K905654 Active Cleared 18 Mar 1991

• Hyfrecator 2000

  Class II

  FDA 510(k) K970493 Active Cleared 30 Apr 1997

• Hand-Trol S

  Class II

  FDA 510(k) K931215 Active Cleared 28 Mar 1994

• Single Use Laparscopic Electrode

  Class II

  FDA 510(k) K904240 Active Cleared 19 Feb 1991

• Single Use Lee Electrode

  Class II

  FDA 510(k) K912046 Active Cleared 5 Mar 1992

• What types of gynecological procedures is this tungsten wire loop electrode designed for, and how does it help during those procedures?

  This single-use tungsten wire loop electrode is specifically designed for Loop Electrosurgical Excision Procedure (LEEP) and Large Loop Excision of the Transformation Zone (LLETZ). It excises abnormal tissue—such as cervical dysplasia—with precision while minimizing thermal damage to surrounding healthy tissue, reducing complications like scarring or excessive bleeding.

• Is this electrode reusable, or is it meant for one-time use only? How should it be handled after use?

  The electrode is strictly single-use only and must be discarded after a single procedure. Since it’s sterile upon packaging, reuse could compromise patient safety by introducing contamination or altering its performance. Follow standard sterile surgical instrument protocols for storage and handling, including proper disposal after use.

• Are there different sizes or models available for this electrode, and how would I determine the right one for a patient?

  The provided data does not specify individual sizes or model variants for this electrode. Selection typically depends on clinical judgment and the specific procedure requirements (e.g., tissue thickness or lesion size). Consult the manufacturer’s instructions or a gynecologist’s guidance to ensure compatibility with the intended use.

• How should this device be stored to maintain its sterility and functionality before use?

  Store the electrode in its original, unopened sterile packaging in a clean, dry environment away from direct sunlight or extreme temperatures. Avoid exposure to moisture or contaminants. Since it’s single-use, ensure the seal remains intact until immediately before use to preserve sterility and performance.

• What regulatory pathway was followed for this device’s approval, and how does that affect its use in clinical settings?

  This electrode received FDA 510(k) clearance (K925333) under the Traditional pathway, demonstrating it is *substantially equivalent* to a legally marketed predicate device. Clinically, this means it meets established safety and effectiveness standards for electrocautery instruments in obstetrics/gynecology, but always verify compliance with your facility’s protocols and manufacturer guidelines for proper use.