Ergon Medical, Ltd.
United KingdomFDA 510(k) applicant, unverified
- Devices
- 1
What Ergon Medical, Ltd. makes
Ergon Medical, Ltd. manufactures the PROLONG device, a medical product designed for prolonged catheter dwell time to reduce the risk of infection and obstruction in urinary drainage applications.
The company’s portfolio is regulated under Class II devices in the U.S. and includes products listed via FDA 510(k) clearance. The manufacturer is based in the United States.
Catalogue
Prolong Ref DEN130047
De Novo 510(k)
Frequently asked questions
How many devices does Ergon Medical, Ltd. have in the registry?
The registry currently lists 1 device for Ergon Medical, Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Ergon Medical, Ltd.'s devices?
Among its 1 most recently registered device, Ergon Medical, Ltd. has devices listed in FDA 510(k) (1 device).
What risk classes do Ergon Medical, Ltd.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Ergon Medical, Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Ergon Medical, Ltd. in the registry?
The most recently registered devices listed for Ergon Medical, Ltd. include PROLONG.