Estech Cobra Genesis Bipolar Clamp

No FDA recalls on record, checked 22 Oct 2026.

Full name

Estech Cobra(R) Genesis Bipolar Clamp

510(k) Number

K133017 ↗

FDA Product Code

GEI

Device Class

Class II

Regulation

21 CFR Part 878.4400

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Cobra Adhere Surgical System

  Class II

  FDA 510(k) K041599 Active Cleared 27 Jul 2004

• Remote Access Perfusion (RAP) Femoral Venous Cannula

  Class II

  FDA 510(k) K052081 Active Cleared 16 Dec 2005

• Remote Access Perfusion Cannula Left Axillary 21 French

  Class II

  FDA 510(k) K032632 Active Cleared 22 Oct 2003

• Estech Arterial Remote Access Perfusion Cannula

  Class II

  FDA 510(k) K990573 Active Cleared 11 Mar 1999

• Estech Clearview Mv Atrial Depressor

  Class II

  FDA 510(k) K053021 Active Cleared 26 Jan 2006

• Cobra Surgical System

  Class II

  FDA 510(k) K051749 Active Cleared 13 Sep 2005

• What is the Estech Cobra Genesis Bipolar Clamp used for?

  The Estech Cobra Genesis Bipolar Clamp is designed for surgical procedures requiring precise tissue management, such as soft tissue dissection, hemostasis, or localized tissue ablation. Its bipolar design ensures controlled energy delivery through integrated electrodes on the clamp jaws, reducing collateral damage to surrounding tissues. This makes it particularly useful in general and plastic surgery where targeted coagulation or cutting is needed.

• How is the Estech Cobra Genesis Bipolar Clamp supplied and what does this mean for use?

  The Estech Cobra Genesis Bipolar Clamp is supplied as a sterile, single-use device. This means each clamp is packaged individually to prevent contamination and is intended for one-time use only. Single-use devices reduce the risk of cross-infection and eliminate the need for reprocessing, ensuring consistent performance and patient safety per standard surgical protocols.

• Is the Estech Cobra Genesis Bipolar Clamp reusable, and if not, why?

  No, the Estech Cobra Genesis Bipolar Clamp is not reusable. It is explicitly designed as a single-use device to maintain sterility and reliability. Reusing electrosurgical instruments can compromise their performance, introduce infection risks, and violate manufacturer guidelines. Single-use devices are engineered for one surgical procedure, ensuring optimal functionality and compliance with infection control standards.

• What safety considerations should be taken when using the Estech Cobra Genesis Bipolar Clamp?

  The Estech Cobra Genesis Bipolar Clamp is non-MRI compatible, meaning it should not be used or stored near MRI equipment, as it could interfere with imaging or pose safety risks. Additionally, it must be handled according to standard electrosurgical safety protocols, including proper grounding of the patient and avoiding contact with flammable materials. Adherence to these protocols ensures safe and effective use during surgery.

• What regulatory approval does the Estech Cobra Genesis Bipolar Clamp have, and what does this mean for clinicians?

  The Estech Cobra Genesis Bipolar Clamp holds FDA 510(k) clearance (K133017) under Special Review for Substantial Equivalence in the General, Plastic Surgery category. This means the device has been evaluated by the FDA and deemed substantially equivalent to a legally marketed predicate device, ensuring it meets established safety and performance standards. Clinicians can rely on this approval as confirmation of the device’s regulatory compliance for use in surgical settings.