Urologics, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
What Urologics, Inc. makes
Urologics, Inc. manufactures the UROSTAT, a device designed for urological applications, and the iUSTIM, an electronic neuromuscular stimulator intended for bladder and pelvic floor management.
The company’s portfolio is regulated under Class II devices in the US, with products listed via the FDA’s 510(k) pathway. The manufacturer is based in the United States.
Catalogue
Urostat Ref K854539
Regimes: 510(k) Registry: 510(k)}iustim - Electronic Neuromuscular Stimulator Ref K850167
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Urologics, Inc. have in the registry?
The registry currently lists 2 devices for Urologics, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Urologics, Inc.'s devices?
Among its 2 most recently registered devices, Urologics, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Urologics, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Urologics, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Urologics, Inc. in the registry?
The most recently registered devices listed for Urologics, Inc. include UROSTAT and }IUSTIM - ELECTRONIC NEUROMUSCULAR STIMULATOR.