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FDA 510(k)

EDWARDS E360 SURGICAL ABLATION DEVICE

K-Number: K041739 · 2004-09-29

ApplicantEdwards Lifesciences, LLC
Decision Date2004-09-29
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

EDWARDS E360 SURGICAL ABLATION DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Edwards Lifesciences, LLC. It received FDA 510(k) clearance on 2004-09-29 under 510(k) number K041739. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EDWARDS E360 SURGICAL ABLATION DEVICE?

EDWARDS E360 SURGICAL ABLATION DEVICE is a medical device that received FDA 510(k) clearance on 2004-09-29. The listed applicant is Edwards Lifesciences, LLC. The 510(k) number is K041739.

When did EDWARDS E360 SURGICAL ABLATION DEVICE receive FDA 510(k) clearance?

EDWARDS E360 SURGICAL ABLATION DEVICE received FDA 510(k) clearance on 2004-09-29, under 510(k) number K041739.

Who is the listed applicant for EDWARDS E360 SURGICAL ABLATION DEVICE?

The FDA 510(k) record lists Edwards Lifesciences, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EDWARDS E360 SURGICAL ABLATION DEVICE?

The FDA product code for EDWARDS E360 SURGICAL ABLATION DEVICE is GEX. This falls under the Gastroenterology category.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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