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FDA 510(k)

Ellusa Bipolar Wands

K-Number: K202558 · 2020-11-02

ApplicantEllusa, LLC
Decision Date2020-11-02
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Ellusa Bipolar Wands is the device name listed in this FDA 510(k) record. The listed applicant is Ellusa, LLC. It received FDA 510(k) clearance on 2020-11-02 under 510(k) number K202558. 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 Ellusa Bipolar Wands?

Ellusa Bipolar Wands is a medical device that received FDA 510(k) clearance on 2020-11-02. The listed applicant is Ellusa, LLC. The 510(k) number is K202558.

When did Ellusa Bipolar Wands receive FDA 510(k) clearance?

Ellusa Bipolar Wands received FDA 510(k) clearance on 2020-11-02, under 510(k) number K202558.

Who is the listed applicant for Ellusa Bipolar Wands?

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

What is the FDA product code for Ellusa Bipolar Wands?

The FDA product code for Ellusa Bipolar Wands is GEI.

Other records listing Ellusa, 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.

K222429Ellusa Reusable Bipolar CableK222425Ellusa Reusable Neutral PlatesK202562Ellusa Generator, Ellusa Bayonet Tip, Ellusa RF-Cobb Tip, Ellusa SP-Pack and Tips, Ellusa Tip Set

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

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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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