Curaseal, Inc.
Country not established
- Devices
- 1
What Curaseal, Inc. makes
Curaseal, Inc. manufactures the CuraSeal Percutaneous Intraluminal Closure System for Anorectal Fistulas (PICS-AF), a device designed for the endoscopic treatment of anorectal fistulas. This system is intended to provide a percutaneous approach to close abnormal connections between the anal canal and surrounding tissues. The device is engineered to deliver a sealing mechanism within the fistula tract, aiming to promote natural healing.
The CuraSeal PICS-AF is classified as a Class II medical device under FDA regulations and is authorised through the 510(k) clearance pathway. The company is based in the United States. No other regulatory listings or device classes are specified for this manufacturer.
Catalogue
- 510(k) 510(k)
Frequently asked questions
How many devices does Curaseal, Inc. have in the registry?
The registry currently lists 1 device for Curaseal, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Curaseal, Inc.'s devices?
Among its 1 most recently registered device, Curaseal, Inc. has devices listed in FDA 510(k) (1 device).
What risk classes do Curaseal, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Curaseal, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Curaseal, Inc. in the registry?
The most recently registered devices listed for Curaseal, Inc. include CuraSeal Percutaneous Intraluminal Closure System for Anorectal Fistulas(PICS-AF).