Habib 4X Laparoscopic

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

510(k) Number

K062935 ↗

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 is the Habib 4X Laparoscopic device used for?

  The Habib 4X Laparoscopic is a single-use device designed to assist in intraoperative coagulation of tissue during laparoscopic surgical procedures. It helps coagulate a surgical resection plane to facilitate fast dissection with limited blood loss, particularly in liver and kidney surgeries.

• How is the Habib 4X Laparoscopic device supplied?

  The device is supplied as a single-use device, meaning it is intended for one surgical procedure only and should not be reused. This ensures sterility and optimal performance for each patient.

• What regulatory approvals does the Habib 4X Laparoscopic have?

  The Habib 4X Laparoscopic has received FDA 510(k) clearance with the product code GEI. This means it has been determined to be substantially equivalent to legally marketed predicate devices for its intended use in laparoscopic procedures.

• In which surgical procedures is the Habib 4X Laparoscopic commonly used?

  The device is commonly used in various surgical procedures, particularly liver and kidney surgeries. It helps minimize blood loss during these procedures and can reduce the need for blood transfusion by creating a coagulated resection plane that facilitates dissection.