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)

DiLumen Endolumenal Interventional Scissors (DiLumen Is)

K-Number: K173405 · 2018-05-22

ApplicantLumendi, LLC
Decision Date2018-05-22
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DiLumen Endolumenal Interventional Scissors (DiLumen Is) is the device name listed in this FDA 510(k) record. The listed applicant is Lumendi, LLC. It received FDA 510(k) clearance on 2018-05-22 under 510(k) number K173405. 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 DiLumen Endolumenal Interventional Scissors (DiLumen Is)?

DiLumen Endolumenal Interventional Scissors (DiLumen Is) is a medical device that received FDA 510(k) clearance on 2018-05-22. The listed applicant is Lumendi, LLC. The 510(k) number is K173405.

When did DiLumen Endolumenal Interventional Scissors (DiLumen Is) receive FDA 510(k) clearance?

DiLumen Endolumenal Interventional Scissors (DiLumen Is) received FDA 510(k) clearance on 2018-05-22, under 510(k) number K173405.

Who is the listed applicant for DiLumen Endolumenal Interventional Scissors (DiLumen Is)?

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

What is the FDA product code for DiLumen Endolumenal Interventional Scissors (DiLumen Is)?

The FDA product code for DiLumen Endolumenal Interventional Scissors (DiLumen Is) is GEI.

Other records listing Lumendi, 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.

K221452DiLumen C1, EZ1 and Tool MountK211819DiLumen C2 and Tool MountK210851DiLumen Endolumenal Interventional Platform (DiLumen)K183112DiLumen Endolumenal Interventional Knife (“DiLumen IK™”)K182540DiLumen Endolumenal Interventional PlatformK173317DiLumen C2; DiLumen Tool Mount

View all 8 devices →

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.

↑