Urogyn, Ltd.
Country not established
- Devices
- 2
What Urogyn, Ltd. makes
Urogyn, Ltd. manufactures manual urological digital needle drivers, including models like the DND 202, designed for precise tissue penetration in surgical procedures.
These devices are classified as Class II under FDA regulations and are listed via 510(k) clearance. The company is based in the United States.
Catalogue
Dnd 101 Ref K001590
Regimes: 510(k) Registry: 510(k)Dnd 202 Manual Urological Digital Needle Driver Ref K014248
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Urogyn, Ltd. have in the registry?
The registry currently lists 2 devices for Urogyn, Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Urogyn, Ltd.'s devices?
Among its 2 most recently registered devices, Urogyn, Ltd. has devices listed in FDA 510(k) (2 devices).
What risk classes do Urogyn, Ltd.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Urogyn, Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Urogyn, Ltd. in the registry?
The most recently registered devices listed for Urogyn, Ltd. include DND 101 and DND 202 MANUAL UROLOGICAL DIGITAL NEEDLE DRIVER.