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FDA 510(k)

EC 2.7 ENDOSCOPIC CUTTER

K-Number: K120909 · 2012-11-02

ApplicantMedtronic Advanced Energy, LLC
Decision Date2012-11-02
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

EC 2.7 ENDOSCOPIC CUTTER is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Advanced Energy, LLC. It received FDA 510(k) clearance on 2012-11-02 under 510(k) number K120909. 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 EC 2.7 ENDOSCOPIC CUTTER?

EC 2.7 ENDOSCOPIC CUTTER is a medical device that received FDA 510(k) clearance on 2012-11-02. The listed applicant is Medtronic Advanced Energy, LLC. The 510(k) number is K120909.

When did EC 2.7 ENDOSCOPIC CUTTER receive FDA 510(k) clearance?

EC 2.7 ENDOSCOPIC CUTTER received FDA 510(k) clearance on 2012-11-02, under 510(k) number K120909.

Who is the listed applicant for EC 2.7 ENDOSCOPIC CUTTER?

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

What is the FDA product code for EC 2.7 ENDOSCOPIC CUTTER?

The FDA product code for EC 2.7 ENDOSCOPIC CUTTER is GEI.

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Official Source

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

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