Skip to content

Cool-Tec Electrodes

by Seedling Enterprises., LLC 2 variants

510(k) K001723

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK001723 Date19 Jul 2000ClearedStatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
GEI
Device Class
Class II
Regulation
21 CFR Part 878.4400
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

Cool-Tec Electrodes are electrosurgical accessories designed for tissue removal and hemostasis using high-frequency electrical current. These devices are classified under the product code GEI and are intended for use with electrosurgical systems to cut and coagulate tissue during surgical procedures.

The electrodes are supplied as single-use items and are regulated under FDA 510(k) clearance (K001723, K002841) as substantially equivalent devices. They are intended for use in sterile surgical settings and must be handled according to manufacturer guidelines to ensure proper functionality and safety. No additional regulatory status beyond the stated FDA clearances is implied.

Other devices from Seedling Enterprises., LLC

Questions

AI-generated answers, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • Are the Cool-Tec Electrodes reusable or designed for single-use only, and how should they be handled to maintain sterility?

    The Cool-Tec Electrodes are explicitly designed for single-use only. Since they are intended for sterile surgical settings, they must be handled as sterile devices. Once opened or used, they should not be reused to prevent contamination and ensure patient safety, as per manufacturer guidelines.

  • What types of surgical procedures are these electrodes intended to assist with, and how do they function?

    The Cool-Tec Electrodes are electrosurgical accessories intended for tissue removal and hemostasis during surgical procedures. They work by delivering high-frequency electrical current to cut and coagulate tissue when used with compatible electrosurgical systems. They are classified under product code GEI for general electrosurgical purposes.

  • What regulatory pathway was followed for FDA clearance of these electrodes, and what does that mean for their use?

    The Cool-Tec Electrodes received FDA 510(k) clearance under the Traditional pathway, with decision codes SESE (Substantially Equivalent) and reviewed by the General, Plastic Surgery (SU) Advisory Committee. This means they were determined to be substantially equivalent to legally marketed devices already on the market, ensuring they meet FDA safety and performance standards for electrosurgical use.

  • Are there different sizes or models available for the Cool-Tec Electrodes, and if so, how would a clinician choose the right one?

    The provided data does not specify individual sizes or models for the Cool-Tec Electrodes. However, since they are electrosurgical accessories, they may come in variations (e.g., tip shapes, lengths, or configurations) to suit different surgical needs. Clinicians should refer to the manufacturer’s documentation or consult with their supplier to select the appropriate electrode for their specific procedure.