FDA 510(k)

PlasmaBlade X 3.0S, PlasmaBlade X 4.0

K-Number: K181257 · 2018-08-02

Decision Date2018-08-02

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

PlasmaBlade X 3.0S, PlasmaBlade X 4.0 is a medical device manufactured by Medtronic Advanced Energy. It received FDA 510(k) clearance on 2018-08-02 under approval number K181257. 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 X 3.0S, PlasmaBlade X 4.0?

PlasmaBlade X 3.0S, PlasmaBlade X 4.0 is a medical device that received FDA 510(k) clearance on 2018-08-02. It is manufactured by Medtronic Advanced Energy. The 510(k) number is K181257.

When was PlasmaBlade X 3.0S, PlasmaBlade X 4.0 approved by the FDA?

PlasmaBlade X 3.0S, PlasmaBlade X 4.0 received FDA 510(k) clearance on 2018-08-02, under approval number K181257.

What company makes PlasmaBlade X 3.0S, PlasmaBlade X 4.0?

PlasmaBlade X 3.0S, PlasmaBlade X 4.0 is manufactured by Medtronic Advanced Energy.

What is the FDA product code for PlasmaBlade X 3.0S, PlasmaBlade X 4.0?

The FDA product code for PlasmaBlade X 3.0S, PlasmaBlade X 4.0 is GEI.

Other Devices by Medtronic Advanced Energy

K152703PlasmaBlade TnA Tonsil and Adenoid Dissection Device K170381Minimally Invasive Sealer (MIS) Flex, Minimally Invasive Sealer (MIS) Flex Mini K170610PlasmaBlade T K170296CoreCath 2.7S K183129Medtronic Total Hip Arthroplasty System

Related Devices (Code: GEI)

K161307NICO MyriadNico Corporation K163190InMode RF SystemInmode MD , Ltd. K163373PK AIMGyrus Acmi, Inc. K163106CODMAN Integrated Bipolar Cord and Tubing SetMedos International SARL K162676Voyant Open Fusion DeviceApplied Medical Resources K162941Ligasure Blunt Tip, Sealer/Divider, Nano-coatedCovidien

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.