Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3026671998

FEI Number

3026671998

Entity Name

ENDOLUMIK

City/State/Country

Morgantown, WV, US

Establishment Address

364 Patteson Dr. #293, Morgantown, WV 26505, US

Establishment Type(s)

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

Owner / Operator

Endolumik (Owner Number: 10087525)

Owner / Operator Contact Address

364 Patteson Dr. #293, Morgantown, WV 26505, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Endolumik GCT M Series Endolumik Gastric Calibration Tube

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FAT	Bougie, Esophageal, And Gastrointestinal, Gastro-Urology	Gastroenterology, Urology	Class 2	876.5365	2024-02-22
KNT	Tubes, Gastrointestinal (And Accessories)	Gastroenterology, Urology	Class 2	876.5980	2024-02-22
FAT	Bougie, Esophageal, And Gastrointestinal, Gastro-Urology	Gastroenterology, Urology	Class 2	876.5365	2023-05-16

Official Correspondent

Mara McFadden

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Endolumik

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
K900590	Biosearch Medical Products, Inc.	BIOSEARCH DOBBHOFF(R) GASTROTRAC JEJUNAL FEEDING	1990-08-02
K102548	Footprint Medical, Inc.	FOOTPRINT MEDICAL POLYURETHANE FEEDING TUBE	2010-11-26
K955248	United States Endoscopy Group, Inc.	U.S. ENDOSCOPY PULL PEG KIT & U.S. ENDOSCOPY GUIDEWIRE PEG KIT	1996-05-21
K872921	Medical Support, Inc.	MSS ENTERAL DELIVERY SET	1987-12-03
K180622	Covidien	Kangaroo Gastrostomy Feeding Tube with ENFit Y-Port	2018-10-23

Similar Registrations

Registration Number	Establishment Name	Location
3010041511	Teleflex LLC (NADC)	Olive Branch, MS, US
3011137372	Teleflex Medical LLC	Morrisville, NC, US
3023657851	INKA SURGICAL INSTRUMENTS	Jandakot Western Australia, AU
3006750742	CHANGZHOU JIUHONG MEDICAL INSTRUMENT CO., LTD.	CHANGZHOU Jiangsu, CN
3004365956	Teleflex Medical de Mexico, S. de R.L. de C.V.	NUEVO LAREDO Tamaulipas, MX

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3026671998. Last updated year: 2026. Please use registration number 3026671998 when referencing this establishment in official correspondence.