Surgin, Inc.
Country not established
- Devices
- 1
What Surgin, Inc. makes
Surgin, Inc. manufactures the PRIZM Keratome Blade (Nidek Model, MK8514NI), a surgical cutting instrument designed for corneal surgery procedures.
The company’s portfolio is regulated under FDA’s Class I device classification, with the PRIZM Keratome Blade listed via a 510(k) submission. The company is based in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Surgin, Inc. have in the registry?
The registry currently lists 1 device for Surgin, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Surgin, Inc.'s devices?
Among its 1 most recently registered device, Surgin, Inc. has devices listed in FDA 510(k) (1 device).
What risk classes do Surgin, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Surgin, Inc.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Surgin, Inc. in the registry?
The most recently registered devices listed for Surgin, Inc. include PRIZM KERATOME BLADE (NIDEK MODEL), MODEL MK8514NI.