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AblatePal Radiofrequency Ablation System

by Compal Electronics, Inc.

510(k) K223135

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 NumberK223135 Date30 Jun 2023ClearedStatusActive

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  • Withdrawn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, 26 Sep 2026

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

The AblatePal Radiofrequency Ablation System is a medical device designed to provide monopolar radiofrequency energy for the coagulation and ablation of soft tissue. It is classified as a Class 2 medical device. The system is intended to deliver radiofrequency energy for therapeutic purposes. The device has advanced features to ensure predictable ablation while minimizing tissue damage.

The AblatePal Radiofrequency Ablation System is supplied by Compal Electronics, Inc. and has received FDA 510(k) clearance. The device is available with a product code of GEI and has a unique k number, K223135. The system is designed for use in medical settings, with a user-centered approach prioritizing doctors' comfort.

Other devices from Compal Electronics, Inc.

Questions

AI-generated answers, 26 Sep 2026

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

  • What is the AblatePal Radiofrequency Ablation System used for?

    The AblatePal System is used for the coagulation and ablation of soft tissue, providing therapeutic purposes with minimal tissue damage.

  • Is the AblatePal System supplied sterile?

    The description does not specify if the AblatePal System is supplied sterile, but it is designed for use in medical settings with a focus on doctor comfort and patient safety.

  • What is the regulatory status of the AblatePal System?

    The AblatePal System has received FDA 510(k) clearance, indicating it is substantially equivalent to a predicate device.

  • What are the available product codes for the AblatePal System?

    The AblatePal System has a product code of GEI and a unique k number, K223135.