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FDA 510(k)

Reusable Monopolar Active Cord

K-Number: K192518 · 2019-10-25

ApplicantUs Endoscopy
Decision Date2019-10-25
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Reusable Monopolar Active Cord is the device name listed in this FDA 510(k) record. The listed applicant is Us Endoscopy. It received FDA 510(k) clearance on 2019-10-25 under 510(k) number K192518. 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 Reusable Monopolar Active Cord?

Reusable Monopolar Active Cord is a medical device that received FDA 510(k) clearance on 2019-10-25. The listed applicant is Us Endoscopy. The 510(k) number is K192518.

When did Reusable Monopolar Active Cord receive FDA 510(k) clearance?

Reusable Monopolar Active Cord received FDA 510(k) clearance on 2019-10-25, under 510(k) number K192518.

Who is the listed applicant for Reusable Monopolar Active Cord?

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

What is the FDA product code for Reusable Monopolar Active Cord?

The FDA product code for Reusable Monopolar Active Cord is GEI.

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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