FDA 510(k)

PlasmaBlade TnA Tonsil and Adenoid Dissection Device

K-Number: K152703 · 2016-07-08

Decision Date2016-07-08

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

PlasmaBlade TnA Tonsil and Adenoid Dissection Device is a medical device manufactured by Medtronic Advanced Energy. It received FDA 510(k) clearance on 2016-07-08 under approval number K152703. 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 PlasmaBlade TnA Tonsil and Adenoid Dissection Device?

PlasmaBlade TnA Tonsil and Adenoid Dissection Device is a medical device that received FDA 510(k) clearance on 2016-07-08. It is manufactured by Medtronic Advanced Energy. The 510(k) number is K152703.

When was PlasmaBlade TnA Tonsil and Adenoid Dissection Device approved by the FDA?

PlasmaBlade TnA Tonsil and Adenoid Dissection Device received FDA 510(k) clearance on 2016-07-08, under approval number K152703.

What company makes PlasmaBlade TnA Tonsil and Adenoid Dissection Device?

PlasmaBlade TnA Tonsil and Adenoid Dissection Device is manufactured by Medtronic Advanced Energy.

What is the FDA product code for PlasmaBlade TnA Tonsil and Adenoid Dissection Device?

The FDA product code for PlasmaBlade TnA Tonsil and Adenoid Dissection Device 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.