Curon Medical, Inc.
United StatesFDA 510(k) applicant, unverified
- Devices
- 3
- FDA recalls
- 1
At a glance
Market reach
- United States
- FDA recalls
What Curon Medical, Inc. makes
Curon Medical produces electrosurgical generators and associated accessories, including the CURON CONTROL MODULE (models S500-ST and S400) and algorithm enhancements for these systems. Their portfolio also includes the SECCA SYSTEM, designed for surgical applications requiring precise energy delivery.
The company’s devices are classified as Class II under FDA regulations and are authorised via the 510(k) pathway. These products are listed in the FDA’s 510(k) database. Curon Medical is based in the United States.
Catalogue
- 510(k) 510(k)
Secca System Ref K014216
510(k) 510(k)- 510(k) 510(k)
FDA recalls
FDA recall records list 1 recall initiated by Curon Medical, Inc., initiated on 2003-02-21. By recorded status: 1 terminated. The reasons filed fall into these groups: mechanical integrity. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2003
- 21 Feb 2003 Z-0663-03 Unclassified (pre-2012) Terminated Catheter shaft has potential to crack during use.
Full distribution text
- 21 Feb 2003 Z-0663-03 Unclassified (pre-2012) Terminated Catheter shaft has potential to crack during use.
Frequently asked questions
How many devices does Curon Medical, Inc. have in the registry?
The registry currently lists 3 devices for Curon Medical, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Curon Medical, Inc.'s devices?
Among its 3 most recently registered devices, Curon Medical, Inc. has devices listed in FDA 510(k) (3 devices).
What risk classes do Curon Medical, Inc.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Curon Medical, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Curon Medical, Inc.?
FDA recall records list 1 recall initiated by Curon Medical, Inc., the most recent initiated on 2003-02-21. 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 Curon Medical, Inc. in the registry?
The most recently registered devices listed for Curon Medical, Inc. include CURON CONTROL MODULE ELECTROSURGICAL GENERATOR AND ACCESSORIES, MODEL S500-ST, SECCA SYSTEM and CONTROL MODULE ALGORITHM ENHANCEMENT FOR THE MODEL S500-ST AND MODEL S400.