Cooper Surgical/Aesthete
Country not established
- Devices
- 1
What Cooper Surgical/Aesthete makes
The company produces areola/nipple dressings, designed for post-surgical care following procedures such as breast reconstruction or nipple-areola complex reconstruction. These products are intended to protect and promote healing of the nipple and surrounding tissue while reducing irritation or infection risk.
The portfolio is classified under FDA Class I medical devices and requires 510(k) clearance for market authorisation. The company is based in the United States and its products are listed in the FDA’s 510(k) registry.
Catalogue
Areola/Nipple Dressing Ref K882558
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Cooper Surgical/Aesthete have in the registry?
The registry currently lists 1 device for Cooper Surgical/Aesthete. Devices recorded under merged duplicate company entries are counted once.
Which registries list Cooper Surgical/Aesthete's devices?
Among its 1 most recently registered device, Cooper Surgical/Aesthete has devices listed in FDA 510(k) (1 device).
What risk classes do Cooper Surgical/Aesthete's devices fall under?
Among its 1 most recently registered device, the classes recorded for Cooper Surgical/Aesthete's devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Cooper Surgical/Aesthete in the registry?
The most recently registered devices listed for Cooper Surgical/Aesthete include AREOLA/NIPPLE DRESSING.