Data / Medical devices / France / Axess Vision Technology
Axess Vision Technology: FDA-registered device maker in Joue Les Tours Indre-et-Loire, France, 2 510(k) clearances
Axess Vision Technology is registered with the FDA (registration 3017859830) in Joue Les Tours Indre-et-Loire, France. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated February 16, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3017859830
- Address
- Zone de la Liodiere 6 Rue De La Flottiere, Joue Les Tours Indre-et-Loire, France, 37300
- Owner or operator
- AXESS VISION TECHNOLOGY (10079489)
- Roles
- Manufacturer
- First device listed
- December 9, 2020
- Registered through
- 2026
- Brand names listed
- Broncoflex Agile, Broncoflex Vortex, Broncoflex XFlo, Easy BAL Clip, Screeni
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Bronchoscope (Flexible Or Rigid) | EOQ | 2 | Manufacturer | accessdata.fda.gov |
| Instrument, Manual, Surgical, General Use | MDM | 1 | Manufacturer | 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 |
|---|---|---|---|---|---|---|
| February 16, 2022 | K212886 | Broncoflex Agile, Broncoflex Vortex, Screeni | EOQ | Substantially Equivalent | Axess Vision Technology | accessdata.fda.gov |
| October 22, 2020 | K202180 | Broncoflex Agile; Product Reference: 20030001 , Broncoflex Vortex; Product Reference: 10030001, Screeni; Product Reference: 30030001 | EOQ | Substantially Equivalent | Axess Vision Technology | accessdata.fda.gov |
Compare with other makers
- All makers of Instrument, Manual, Surgical, General Use
- All makers of Bronchoscope (Flexible Or Rigid)
Updated February 16, 2022. 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.