Data / Medical devices / United States / ENvue Medical (USA) Inc.
ENvue Medical (USA) Inc.: FDA-registered device maker in Arlington Heights, IL, United States, 2 510(k) clearances
ENvue Medical (USA) Inc. is registered with the FDA (registration 3017081712) in Arlington Heights, IL, United States. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated March 24, 2021. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3017081712
- Address
- 762 W. Algonquin Road, Arlington Heights, IL, United States, 60005
- Owner or operator
- ENvizion Medical Ltd (10048397)
- Roles
- Specification developer
- First device listed
- January 17, 2020
- Registered through
- 2026
- Brand names listed
- ENvizion Medical ENVue SYSTEM, ENvizion Medical Enteral Feeding Tube, ENvue ENvizion Medical Enteral Feeding Tube
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Gastrointestinal Tubes With Enteral Specific Connectors | PIF | 2 | Specification developer | accessdata.fda.gov |
| Tubes, Gastrointestinal (And Accessories) | KNT | 2 | Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| March 24, 2021 | K203133 | ENvizion Medical ENvue ENvizion Medical Enteral Feeding Tube | KNT | Substantially Equivalent | Envizion Medical , Ltd. | accessdata.fda.gov |
| June 14, 2019 | K191387 | ENvizion Medical ENVue SYSTEM, ENvizion Medical Enteral Feeding Tube | KNT | Substantially Equivalent | Envizion Medical , Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Gastrointestinal Tubes With Enteral Specific Connectors
- All makers of Tubes, Gastrointestinal (And Accessories)
Updated March 24, 2021. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.