Laparoscopic Electrosurgical Cannula W/Retractable

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

510(k) Number

K912637 ↗

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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• Dexide Laparoscopic Accessories

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See all devices from Dexide, Inc. →

• What is the Laparoscopic Electrosurgical Cannula with Retractable used for?

  This device is specifically designed for laparoscopic procedures to assist with tissue manipulation, dissection, and electrosurgical coagulation or cutting. Its retractable feature improves precision, reducing the risk of accidental tissue damage during minimally invasive surgeries. It integrates with standard electrosurgical units to enhance control and safety in surgical settings.

• Is the Laparoscopic Electrosurgical Cannula with Retractable intended for single-use or reuse?

  The device is intended for single-use in sterile surgical environments, as specified by the manufacturer. This ensures patient safety and sterility, aligning with FDA guidelines for electrosurgical instruments. Reuse is not recommended unless explicitly authorized by the manufacturer’s instructions.

• How should the Laparoscopic Electrosurgical Cannula with Retractable be stored?

  Storage must follow the manufacturer’s instructions to maintain sterility and functionality. The device should be kept in a clean, dry environment, protected from contamination, and away from sources of moisture or extreme temperatures. Proper packaging should be preserved until immediate preoperative use.

• What safety considerations apply when using this device?

  This device requires adherence to standard electrosurgical safety guidelines to prevent unintended tissue damage or equipment malfunction. Compatibility with MRI environments is not specified, so its use should be avoided in such settings unless confirmed by the manufacturer. Always follow sterile surgical protocols and manufacturer instructions for optimal performance.

• What regulatory clearance does the Laparoscopic Electrosurgical Cannula with Retractable hold?

  The device holds FDA 510(k) clearance under the classification of Electrosurgical, Cutting & Coagulation & Accessories (Product Code: GEI). This clearance was granted under Regulation 878.4400, confirming its substantial equivalence to a predicate device. No additional regulatory approvals beyond this clearance are mentioned.