Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3017081712

FEI Number

3017081712

Entity Name

ENvue Medical (USA) Inc.

City/State/Country

Arlington Heights, IL, US

Establishment Address

762 W. Algonquin Road, Arlington Heights, IL 60005, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

ENvizion Medical Ltd (Owner Number: 10048397)

Owner / Operator Contact Address

26 HaBarzel, Tel Aviv, IL-TA 6971036, IL

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K191387

PMA Number

N/A

All Registered Proprietary Names

ENvizion Medical ENVue SYSTEM, ENvizion Medical Enteral Feeding Tube

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KNT	Tubes, Gastrointestinal (And Accessories)	Gastroenterology, Urology	Class 2	876.5980	2020-01-17

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

ENvizion Medical Ltd

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
3025772870	ENTERAL ACCESS TECHNOLOGIES, LTD.	Caerwys Flintshire, GB
3015237508	ADVANCED MEDICAL BALLOONS GMBH	Waghaeusel Baden-Wurttemberg, DE
3009247326	Jabil Circuit (Singapore) Pte Ltd	Singapore Central Singapore, SG
2528981	LYNX Medical Pennsylvania	ERIE, PA, US
1649518	Sterigenics US LLC	Fort Worth, TX, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3017081712. Last updated year: 2026. Please use registration number 3017081712 when referencing this establishment in official correspondence.