Gi Windows
United Statesfrom the FDA registration address FDA establishment FEI 3021969326
- Devices
- 10
- Registrations
- FDA
- FDA recalls
- 0
Catalogue
- Registry: GUDID
- Registry: GUDID
- Registry: GUDID
- Registry: GUDID
- Registry: GUDID
- Registry: GUDID
Self-Forming Magnet (Flexagon Plus OTOLoc) Ref K250541
Regimes: 510(k) Registry: 510(k)Self-Forming Magnet (Flexagon) Ref K243482
Regimes: 510(k) Registry: 510(k)Self-Forming Magnet (FLEX SFM) Ref K243213
Regimes: 510(k) Registry: 510(k)Self-Forming Magnet (Flexagon Plus OTOLoc) Ref K253550
Regimes: 510(k) Registry: 510(k)
Company details
- FDA FEI number
- 3021969326
- Address
- 480 Neponset St Ste 11b1, Canton, MA, 02021
Frequently asked questions
How many devices does GI WINDOWS have in the registry?
The registry currently lists 10 devices for GI WINDOWS. Devices recorded under merged duplicate company entries are counted once.
Which registries list GI WINDOWS's devices?
Among its 10 most recently registered devices, GI WINDOWS has devices listed in FDA 510(k) (4 devices) and FDA GUDID (6 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do GI WINDOWS's devices fall under?
Among its 10 most recently registered devices, the classes recorded for GI WINDOWS's devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from GI WINDOWS in the registry?
The most recently registered devices listed for GI WINDOWS include FlexFire Universal Handpiece 100016, FlexFire Universal Cartridge - Flexagon( A) Plus OTOLoc 100026, FlexFire Universal Cartridge - Flexagon (B) Plus OTOLoc 100027 and FlexFire Universal Cartridge OTOLoc Only 100028.