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FDA 510(k)

ATRICURE BIPOLAR COAGULATION SYSTEM

K-Number: K011722 · 2001-08-30

ApplicantAtriCure, Inc.
Decision Date2001-08-30
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ATRICURE BIPOLAR COAGULATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is AtriCure, Inc.. It received FDA 510(k) clearance on 2001-08-30 under 510(k) number K011722. 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 ATRICURE BIPOLAR COAGULATION SYSTEM?

ATRICURE BIPOLAR COAGULATION SYSTEM is a medical device that received FDA 510(k) clearance on 2001-08-30. The listed applicant is AtriCure, Inc.. The 510(k) number is K011722.

When did ATRICURE BIPOLAR COAGULATION SYSTEM receive FDA 510(k) clearance?

ATRICURE BIPOLAR COAGULATION SYSTEM received FDA 510(k) clearance on 2001-08-30, under 510(k) number K011722.

Who is the listed applicant for ATRICURE BIPOLAR COAGULATION SYSTEM?

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

What is the FDA product code for ATRICURE BIPOLAR COAGULATION SYSTEM?

The FDA product code for ATRICURE BIPOLAR COAGULATION SYSTEM is GEI.

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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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