Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013505983

FEI Number

3013505983

Entity Name

LUMENDI, LLC

City/State/Country

Westport, CT, US

Establishment Address

253 Post Road W, Westport, CT 06880, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Lumendi, LLC (Owner Number: 10054295)

Owner / Operator Contact Address

253 Post Road W, Westport, CT 06880, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K182540

PMA Number

N/A

All Registered Proprietary Names

DiLumen EZ Glide DiLumen Ik, Endolumenal Interventional Kinfe DiLumen Is DiLumen C2 DiLumen Endolumenal Interventional Platform DiLumen Endolumenal Interventional Platform D-1000 DiLumen Endolumenal Interventional Platform D-1002 DiLumen Endolumenal Interventional Platform D-1001

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FDF	Colonoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2021-10-19
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2019-08-28
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2018-05-23
FDF	Colonoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2023-02-16
FDF	Colonoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2017-03-05
FDF	Colonoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2018-12-14

Official Correspondent

Dennis Daniels

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Lumendi, LLC

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K970809	Somnus Medical Technologies, Inc.	BENDABLE TISSUE COAGULATING ELECTRODE WITH BENDING TOOL	1997-06-18
K222793	C.R. Bard, Inc.	WavelinQ Generator	2022-10-17
K002257	Tecno Instruments (Pvt.) , Ltd.	TECNO DISPOSABLE FINGERSWITCH PENCIL, MODEL 150-100	2000-10-19
K193591	Bowa-Electronics GmbH & Co. KG	ARC 400	2020-04-02
K192128	Sutter Medizintechnik GmbH	Sutter Arrowtip Monopolar Electrodes	2019-10-04

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0031-06	Rita Medical Systems	2	Rita Brand Habib 4X Electrosurgical Coagulator, Catalog Number: 4401US; Product is distributed by RITA Medical Systems, Inc., One Horizon Way. Manchester, GA 32826

Similar Registrations

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3009698186	ACTUATED MEDICAL, INC.	Bellefonte, PA, US
9610595	AIZU OLYMPUS CO., LTD.	AIZUWAKAMATSU-SHI Fukushima, JP
3015136743	STERI-TECH CO.,LTD.	KAZO-SHI Saitama, JP
3042225166	FUJIFILM Corporation Medical Systems Research & Development Center Kaisei	Ashigarakami-Gun Kanagawa, JP

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013505983. Last updated year: 2026. Please use registration number 3013505983 when referencing this establishment in official correspondence.