Safestitch Medical
Country not established
- Devices
- 1
What Safestitch Medical makes
Safestitch Medical manufactures the SMART DILATOR, a medical device designed for controlled dilation procedures in clinical settings.
The SMART DILATOR is classified as a Class II device under FDA regulations and is listed in the FDA’s 510(k) clearance registry. The company is based in the United States.
Catalogue
Smart Dilator Ref K082995
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Safestitch Medical have in the registry?
The registry currently lists 1 device for Safestitch Medical. Devices recorded under merged duplicate company entries are counted once.
Which registries list Safestitch Medical's devices?
Among its 1 most recently registered device, Safestitch Medical has devices listed in FDA 510(k) (1 device).
What risk classes do Safestitch Medical's devices fall under?
Among its 1 most recently registered device, the classes recorded for Safestitch Medical's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Safestitch Medical in the registry?
The most recently registered devices listed for Safestitch Medical include SMART DILATOR.