Smith-Collins Pharmaceutical, Inc.
Country not established
- Devices
- 1
What Smith-Collins Pharmaceutical, Inc. makes
Smith-Collins Pharmaceutical, Inc. manufactures external penile rigidity devices designed for treating erectile dysfunction. These devices are intended to provide mechanical support to the penis during sexual activity.
The company’s products fall under FDA Class II medical devices and are authorised via the 510(k) pathway. The manufacturer is based in the United States.
Catalogue
Response External Penile Rigidity Device Ref K900559
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Smith-Collins Pharmaceutical, Inc. have in the registry?
The registry currently lists 1 device for Smith-Collins Pharmaceutical, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Smith-Collins Pharmaceutical, Inc.'s devices?
Among its 1 most recently registered device, Smith-Collins Pharmaceutical, Inc. has devices listed in FDA 510(k) (1 device).
What risk classes do Smith-Collins Pharmaceutical, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Smith-Collins Pharmaceutical, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Smith-Collins Pharmaceutical, Inc. in the registry?
The most recently registered devices listed for Smith-Collins Pharmaceutical, Inc. include RESPONSE EXTERNAL PENILE RIGIDITY DEVICE.