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FDA 510(k)

AQUAMANTYS3 9.5 XL BIPOLAR SEALER

K-Number: K120537 · 2012-05-10

ApplicantMedtronic, Inc.
Decision Date2012-05-10
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

AQUAMANTYS3 9.5 XL BIPOLAR SEALER is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic, Inc.. It received FDA 510(k) clearance on 2012-05-10 under 510(k) number K120537. 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 AQUAMANTYS3 9.5 XL BIPOLAR SEALER?

AQUAMANTYS3 9.5 XL BIPOLAR SEALER is a medical device that received FDA 510(k) clearance on 2012-05-10. The listed applicant is Medtronic, Inc.. The 510(k) number is K120537.

When did AQUAMANTYS3 9.5 XL BIPOLAR SEALER receive FDA 510(k) clearance?

AQUAMANTYS3 9.5 XL BIPOLAR SEALER received FDA 510(k) clearance on 2012-05-10, under 510(k) number K120537.

Who is the listed applicant for AQUAMANTYS3 9.5 XL BIPOLAR SEALER?

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

What is the FDA product code for AQUAMANTYS3 9.5 XL BIPOLAR SEALER?

The FDA product code for AQUAMANTYS3 9.5 XL BIPOLAR SEALER is GEI.

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Related Devices (Code: 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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