Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

PlasmaBlade X 3.0S, PlasmaBlade X 4.0

K-Number: K181257 · 2018-08-02

ApplicantMedtronic Advanced Energy
Decision Date2018-08-02
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PlasmaBlade X 3.0S, PlasmaBlade X 4.0 is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Advanced Energy. It received FDA 510(k) clearance on 2018-08-02 under 510(k) 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. The listed applicant is Medtronic Advanced Energy. The 510(k) number is K181257.

When did PlasmaBlade X 3.0S, PlasmaBlade X 4.0 receive FDA 510(k) clearance?

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

Who is the listed applicant for PlasmaBlade X 3.0S, PlasmaBlade X 4.0?

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

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 records listing Medtronic Advanced Energy 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.

K183129Medtronic Total Hip Arthroplasty SystemK170381Minimally Invasive Sealer (MIS) Flex, Minimally Invasive Sealer (MIS) Flex MiniK170610PlasmaBlade TK170296CoreCath 2.7SK152703PlasmaBlade TnA Tonsil and Adenoid Dissection Device

Related Devices (Code: GEI)

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.

K261179AlphaTriPart - Monopolar MIC InstrumentsGimmi GmbHK253504Volnewmer™Classys, Inc.K254056THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S (TB-0545FCS); THUNDERBEAT 5 mm, 35 cm, Front-actuated Grip Type S (TB-0535FCS); THUNDERBEAT 5 mm, 20 cm, Front-actuated Grip Type S (TB-0520FCS)Olympus Medical Systems Corp.K253484LUTRONIC GENIUSCynosure Lutronic Technology CorporationK251492Irrigation Tubing Bipolar Cord SetNew Deantronics Taiwan , Ltd.K260636Remanufactured LigaSure XP Maryland Jaw Sealer/Divider Without Nano-coatingStryker Sustainability Solutions

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.

↑