Dura Tap, LLC
United StatesFDA 510(k) applicant, unverified
- Devices
- 2
What Dura Tap, LLC makes
Dura Tap, LLC manufactures suture delivery devices, including models incorporating PTFE and polypropylene sutures for specific medical applications. These devices are designed to facilitate precise suture placement in surgical procedures, aiding in tissue approximation and wound closure.
The company’s products are classified as Class II medical devices under FDA regulations and are listed via the 510(k) pathway. These devices are registered in the United States, where the manufacturer is based.
Catalogue
Gazelle PTFE and Suture Delivery Device Ref K173335
510(k) 510(k)Gazelle Polypropylene Suture and Delivery Device Ref K173644
510(k) 510(k)
Frequently asked questions
How many devices does Dura Tap, LLC have in the registry?
The registry currently lists 2 devices for Dura Tap, LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list Dura Tap, LLC's devices?
Among its 2 most recently registered devices, Dura Tap, LLC has devices listed in FDA 510(k) (2 devices).
What risk classes do Dura Tap, LLC's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Dura Tap, LLC's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Dura Tap, LLC in the registry?
The most recently registered devices listed for Dura Tap, LLC include Gazelle PTFE and Suture Delivery Device and Gazelle Polypropylene Suture and Delivery Device.