Coated Laparoscopic Electrosurgical Blades

• • Terminated Z-1250-2022 FDA Class II ·initiated 3 May 2022 ·on shared 510(k) K952204

  Potential for the tip of the electrode to detach during use.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Full name

Conmed/Aspen Labs Coated Laparoscopic Electrosurgical Blades

510(k) Number

K952204 ↗

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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  FDA 510(k) K934828 Active Cleared 7 Mar 1994

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• What are the Conmed Coated Laparoscopic Electrosurgical Blades designed for?

  These blades are specifically designed for laparoscopic surgical procedures to facilitate precise tissue dissection and coagulation. The conductive coating enables controlled application of electrosurgical energy, reducing bleeding and improving surgical outcomes during minimally invasive surgeries.

• Are these blades intended for single-use or reusable applications?

  The Conmed Coated Laparoscopic Electrosurgical Blades are intended for single-use only. They are part of a disposable electrosurgical system, ensuring sterility and safety for each surgical procedure without risk of cross-contamination or degradation from reuse.

• How should these blades be stored to maintain sterility and functionality?

  Storage must follow the manufacturer’s guidelines to preserve sterility and performance. Typically, this involves keeping them in their original, sealed packaging in a clean, dry environment away from direct sunlight or extreme temperatures. Proper storage ensures compliance with surgical best practices and maintains the integrity of the conductive coating.

• What regulatory clearance do these blades hold?

  The Conmed Coated Laparoscopic Electrosurgical Blades are cleared under the FDA 510(k) pathway with clearance number K952204. This classification confirms they meet regulatory standards for electrosurgical cutting and coagulation accessories, ensuring their safety and effectiveness for laparoscopic use.

• Are these blades compatible with all laparoscopic electrosurgical systems?

  While these blades are designed for use with laparoscopic electrosurgical systems, compatibility depends on the specific system’s requirements, such as blade size, connector type, and energy settings. Always verify compatibility with your system’s manufacturer guidelines to ensure proper function and safety during surgery.