Intio, Inc.
Country not established
- Devices
- 1
- FDA recalls
- 1
At a glance
Market reach
- United States
- FDA recalls
What Intio, Inc. makes
Intio, Inc. manufactures the CLEARSTART SVM System, a device designed for surgical smoke management in medical procedures to evacuate, filter, and neutralize surgical smoke and airborne contaminants.
The company’s portfolio is regulated under FDA’s Class II device classification, with the CLEARSTART SVM System authorised via the 510(k) pathway. The device is listed in the FDA’s 510(k) database. Intio, Inc. is based in the United States.
Catalogue
Clearstart Svm System Ref K113541
Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 1 recall initiated by Intio, Inc., initiated on 2013-02-26. By recorded status: 1 terminated. The reasons filed fall into these groups: labeling or instructions for use. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2013
- 26 Feb 2013 Z-0974-2013 Class II Terminated INTIO Inc. distributed a SVM User's Manual and it has an editing mistake that could be interpreted as promoting an unapproved use.
Frequently asked questions
How many devices does Intio, Inc. have in the registry?
The registry currently lists 1 device for Intio, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Intio, Inc.'s devices?
Among its 1 most recently registered device, Intio, Inc. has devices listed in FDA 510(k) (1 device).
What risk classes do Intio, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Intio, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Intio, Inc.?
FDA recall records list 1 recall initiated by Intio, Inc., the most recent initiated on 26 Feb 2013. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Intio, Inc. in the registry?
The most recently registered devices listed for Intio, Inc. include CLEARSTART SVM SYSTEM.