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FDA 510(k)

AblatePal Radiofrequency Ablation System

K-Number: K223135 · 2023-06-30

ApplicantCompal Electronics, Inc.
Decision Date2023-06-30
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

AblatePal Radiofrequency Ablation System is the device name listed in this FDA 510(k) record. The listed applicant is Compal Electronics, Inc.. It received FDA 510(k) clearance on 2023-06-30 under 510(k) number K223135. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AblatePal Radiofrequency Ablation System?

AblatePal Radiofrequency Ablation System is a medical device that received FDA 510(k) clearance on 2023-06-30. The listed applicant is Compal Electronics, Inc.. The 510(k) number is K223135.

When did AblatePal Radiofrequency Ablation System receive FDA 510(k) clearance?

AblatePal Radiofrequency Ablation System received FDA 510(k) clearance on 2023-06-30, under 510(k) number K223135.

Who is the listed applicant for AblatePal Radiofrequency Ablation System?

The FDA 510(k) record lists Compal Electronics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AblatePal Radiofrequency Ablation System?

The FDA product code for AblatePal Radiofrequency Ablation System is GEI.

Other records listing Compal Electronics, Inc. as applicant

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Official Source

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