Bi-Polar Forceps

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K854864 ↗

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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• Surgical Cauteries Models 775-11, 12, 13, 31, 32 & 33

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See all devices from Birtcher Corp. →

• What is the Bi-Polar Forceps designed for in surgical procedures?

  The Bi-Polar Forceps is specifically designed for precise tissue cutting and coagulation during surgical procedures, particularly in general and plastic surgery. It uses bipolar electrosurgical technology to deliver controlled electrical energy through two closely spaced electrodes, enabling hemostasis (stopping blood flow) and incision with minimal collateral thermal damage to adjacent tissues. This reduces the risk of unintended harm to surrounding healthy tissue, making it ideal for delicate surgical applications.

• Is the Bi-Polar Forceps intended for single-use or reusable applications?

  The Bi-Polar Forceps is intended for single-use in sterile surgical settings. While the device is classified under FDA product code GEI for electrosurgical accessories, the manufacturer specifies it as disposable to ensure sterility and safety. Reuse is not recommended unless explicitly stated by the manufacturer’s instructions for use, which should always be followed to maintain device performance and regulatory compliance.

• How should the Bi-Polar Forceps be stored to maintain functionality?

  The Bi-Polar Forceps must be stored according to standard electrosurgical accessory protocols to preserve sterility and functionality. This includes keeping it in a clean, dry environment, away from direct sunlight or extreme temperatures, and following the manufacturer’s packaging instructions. If supplied sterile, it should remain in its original packaging until use to prevent contamination. Always adhere to sterile technique when handling to avoid compromising its intended single-use purpose.

• What regulatory pathway does the Bi-Polar Forceps follow under FDA clearance?

  The Bi-Polar Forceps received FDA clearance under the Traditional 510(k) pathway (K854864) and is classified as Substantially Equivalent (SESE) to a predicate device. It falls under FDA product code GEI (Electrosurgical Cutting and Coagulation Accessories) and is regulated as a Class II device under 21 CFR 878.4400. No third-party review was required for this clearance, and the device is intended for use in general and plastic surgery as per the SU (Surgical) Advisory Committee classification.

• Are there different models or sizes available for the Bi-Polar Forceps?

  The provided data does not specify multiple models or sizes for the Bi-Polar Forceps. However, like many electrosurgical accessories, variations may exist based on manufacturer specifications (e.g., jaw length, tip configuration, or electrode spacing). For exact details on available models or sizing, refer to the manufacturer’s product catalog or instructions for use. Always ensure the selected model aligns with the surgical procedure’s requirements to optimize performance and safety.