DiLumen Endolumenal Interventional Scissors (DiLumen Is)

Electrosurgical, Cutting & Coagulation & Accessories

Lumendi, LLC

The following data is part of a premarket notification filed by Lumendi, Llc with the FDA for Dilumen Endolumenal Interventional Scissors (dilumen Is).

Pre-market Notification Details

Device IDK173405
510k NumberK173405
Device Name:DiLumen Endolumenal Interventional Scissors (DiLumen Is)
ClassificationElectrosurgical, Cutting & Coagulation & Accessories
Applicant Lumendi, LLC 253 Post Road West Westport,  CT  06880
ContactDennis Daniels
CorrespondentJohn J. Smith
Hogan Lovells U.S. LLP 555 13th Street NW Washington,  DC  20004
Product CodeGEI  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-10-31
Decision Date2018-05-22
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00865309000270 K173405 000
00865309000263 K173405 000

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