Uvision360, Inc.
United StatesFDA applicant, unverified
Uvision360, Inc. is a medical device manufacturer, with 14 devices listed in FDA GUDID and FDA 510(k) (FDA Class II and I) as of 14 Nov 2026.
- Devices
- 14
Registry facts
- Registries
- FDA GUDID 10
- FDA 510(k) 4
- Device classes
- FDA Class II 13
- FDA Class I 1
What Uvision360, Inc. makes
Uvision360, Inc. manufactures single-use endoscope sheaths, including disposable diagnostic and biopsy versions with 360° rotational designs, as well as reusable flexible fibreoptic and video cystoscopes. Their portfolio also includes endometrial biopsy curettes and endocervical aspirators, primarily for hysteroscopy and cystoscopy procedures.
The company’s devices are classified under FDA categories Class I and Class II, with submissions recorded in the 510(k) and UDI registries.
Catalogue
Search and filter all 14 devicesFrequently asked questions
How many devices does Uvision360, Inc. have in the registry?
The registry currently lists 14 devices for Uvision360, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Uvision360, Inc.'s devices?
Among its 14 most recently registered devices, Uvision360, Inc. has devices listed in FDA 510(k) (4 devices) and FDA GUDID (10 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Uvision360, Inc.'s devices fall under?
Among its 14 most recently registered devices, the classes recorded for Uvision360, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Uvision360, Inc. in the registry?
The most recently registered devices listed for Uvision360, Inc. include Uvision Hysteroscope Cable 20050, LUMINELLE DTx 360 Rotatable Disposable Sheaths LUMDTx-360, LUMINELLE Bx 360° Rotatable Disposable Sheath (Biopsy) LUMBx-360 DOWN and LUMINELLE Aspirator LUM-A.