Advanced Surgical Innovations, Inc.
CanadaFDA applicant, unverified
- Devices
- 1
What Advanced Surgical Innovations, Inc. makes
Advanced Surgical Innovations, Inc. manufactures surgical mesh products, including the PROLEX MESH, designed for use in hernia repair procedures.
The company’s portfolio is regulated under FDA Class II devices, with products authorised via the 510(k) pathway. The manufacturer is based in the United States.
Catalogue
Prolex Mesh Ref K960219
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Advanced Surgical Innovations, Inc. have in the registry?
The registry currently lists 1 device for Advanced Surgical Innovations, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Advanced Surgical Innovations, Inc.'s devices?
Among its 1 most recently registered device, Advanced Surgical Innovations, Inc. has devices listed in FDA 510(k) (1 device).
What risk classes do Advanced Surgical Innovations, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Advanced Surgical Innovations, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Advanced Surgical Innovations, Inc. in the registry?
The most recently registered devices listed for Advanced Surgical Innovations, Inc. include PROLEX MESH.