Single Use Ball Electrode

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K780976 ↗

FDA Product Code

GEI

Device Class

Class II

Regulation

21 CFR Part 878.4400

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

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• What types of surgical procedures is the Single Use Ball Electrode intended for use in, and how does its design support those applications?

  The Single Use Ball Electrode is designed for precise tissue coagulation and cauterization during surgical procedures, particularly where broad contact with superficial tissue is beneficial. Its spherical distal tip provides a larger contact area compared to traditional electrodes, enabling more controlled energy delivery for effective hemostasis (bleeding control). This makes it ideal for procedures in general surgery or plastic surgery where superficial tissue management is critical, such as excisions, debridements, or minor vascular control.

• Is the Single Use Ball Electrode reusable, or is it meant for single-use only? How does this affect its handling and safety?

  The Single Use Ball Electrode is explicitly designed for single-use only, as stated in its description. This design choice eliminates the risk of cross-contamination between patients and reduces the need for sterilization between uses. The device includes molded electrodes with safety grip insulators, which further enhance patient and user safety by minimizing accidental contact with live electrodes during handling. Single-use also ensures consistent performance and reliability.

• What shaft size and material does the Single Use Ball Electrode use, and how might this influence its use in different surgical settings?

  The electrode features a standard 3⁄32-inch (2.3mm) stainless steel shaft, which balances flexibility and rigidity for precise maneuverability in surgical settings. The stainless steel construction ensures durability and resistance to heat, making it suitable for electrosurgical applications where consistent energy transfer is required. This size is common in electrosurgical accessories, allowing compatibility with most electrosurgical units while providing adequate strength for controlled tissue coagulation.

• How is the Single Use Ball Electrode packaged and stored, and are there any special considerations for maintaining its sterility?

  While the packaging details aren’t specified, the device is sterile as manufactured, which means it is pre-packaged in a sterile barrier system (likely a sealed pouch or sterile wrapper) to preserve sterility until first use. Users should store it in a clean, dry environment away from direct sunlight or extreme temperatures to prevent degradation. Once opened, the electrode should be used immediately to avoid contamination risks, as it is intended for single-use only.

• What regulatory pathway was followed for FDA clearance of the Single Use Ball Electrode, and what does this mean for clinicians or purchasers?

  The Single Use Ball Electrode received FDA 510(k) clearance under the Traditional Review pathway with K-number K780976 and product code GEI (General and Plastic Surgery Electrosurgical Instruments). This means the device was determined to be substantially equivalent to a legally marketed predicate device, ensuring it meets FDA safety and performance standards. Clinicians or purchasers can rely on this clearance as evidence of regulatory scrutiny, though they should always verify compatibility with their specific electrosurgical units and follow manufacturer guidelines for use.