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FDA 510(k)

MicroFrance Monopolar and Bipolar Electrosurgical Instruments

K-Number: K210942 · 2021-05-14

ApplicantIntegra Microfrance
Decision Date2021-05-14
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MicroFrance Monopolar and Bipolar Electrosurgical Instruments is the device name listed in this FDA 510(k) record. The listed applicant is Integra Microfrance. It received FDA 510(k) clearance on 2021-05-14 under 510(k) number K210942. 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 MicroFrance Monopolar and Bipolar Electrosurgical Instruments?

MicroFrance Monopolar and Bipolar Electrosurgical Instruments is a medical device that received FDA 510(k) clearance on 2021-05-14. The listed applicant is Integra Microfrance. The 510(k) number is K210942.

When did MicroFrance Monopolar and Bipolar Electrosurgical Instruments receive FDA 510(k) clearance?

MicroFrance Monopolar and Bipolar Electrosurgical Instruments received FDA 510(k) clearance on 2021-05-14, under 510(k) number K210942.

Who is the listed applicant for MicroFrance Monopolar and Bipolar Electrosurgical Instruments?

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

What is the FDA product code for MicroFrance Monopolar and Bipolar Electrosurgical Instruments?

The FDA product code for MicroFrance Monopolar and Bipolar Electrosurgical Instruments is GEI.

Related Clinical Trials

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.

NCT05272046Monopolar and Bipolar Current RFA Knife in POEMCOMPLETED

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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