Urohealth Systems, Inc.
United StatesFDA applicant, unverified
- Devices
- 3
What Urohealth Systems, Inc. makes
Urohealth Systems, Inc. manufactures medical devices including an intubation endoscope and introducer sheath, a modified reflex automatic end-to-end linear stapler/cutter, and pivotal scissors. These products are designed for surgical and procedural applications, supporting minimally invasive and precise tissue manipulation or closure.
The company’s portfolio consists of Class II devices, all of which are authorised via FDA 510(k) clearance. These devices are listed under U.S. regulatory requirements and are intended for commercial distribution within the United States.
Catalogue
Intubation Endoscope And Introducer Sheath Ref K970107
Regimes: 510(k) Registry: 510(k)Modification To Reflex Aec Linear Stapler/Cutter Ref K980617
Regimes: 510(k) Registry: 510(k)Pivotal Scissor Ref K972510
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Urohealth Systems, Inc. have in the registry?
The registry currently lists 3 devices for Urohealth Systems, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Urohealth Systems, Inc.'s devices?
Among its 3 most recently registered devices, Urohealth Systems, Inc. has devices listed in FDA 510(k) (3 devices).
What risk classes do Urohealth Systems, Inc.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Urohealth Systems, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Urohealth Systems, Inc. in the registry?
The most recently registered devices listed for Urohealth Systems, Inc. include INTUBATION ENDOSCOPE AND INTRODUCER SHEATH, MODIFICATION TO REFLEX AEC LINEAR STAPLER/CUTTER and PIVOTAL SCISSOR.