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FDA 510(k)

AQUAMANTYS ENDO DBS 8.7 DISSECTING BIPOLAR SEALER

K-Number: K123201 · 2013-01-10

ApplicantMedtronic Advanced Energy, LLC
Decision Date2013-01-10
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

AQUAMANTYS ENDO DBS 8.7 DISSECTING BIPOLAR SEALER 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 2013-01-10 under 510(k) number K123201. 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 AQUAMANTYS ENDO DBS 8.7 DISSECTING BIPOLAR SEALER?

AQUAMANTYS ENDO DBS 8.7 DISSECTING BIPOLAR SEALER is a medical device that received FDA 510(k) clearance on 2013-01-10. The listed applicant is Medtronic Advanced Energy, LLC. The 510(k) number is K123201.

When did AQUAMANTYS ENDO DBS 8.7 DISSECTING BIPOLAR SEALER receive FDA 510(k) clearance?

AQUAMANTYS ENDO DBS 8.7 DISSECTING BIPOLAR SEALER received FDA 510(k) clearance on 2013-01-10, under 510(k) number K123201.

Who is the listed applicant for AQUAMANTYS ENDO DBS 8.7 DISSECTING BIPOLAR SEALER?

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 AQUAMANTYS ENDO DBS 8.7 DISSECTING BIPOLAR SEALER?

The FDA product code for AQUAMANTYS ENDO DBS 8.7 DISSECTING BIPOLAR SEALER is GEI.

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Other records listing Medtronic Advanced Energy, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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