Goosen Enterprises, Inc.
United StatesFDA applicant, unverified
- Devices
- 4
What Goosen Enterprises, Inc. makes
Goosen Enterprises, Inc. manufactures urinary catheters, including the Mensink-Goosen and self-lubricating variants, as well as vacuum-powered body fluid suction apparatus like the Acuflo. Their portfolio also includes urinary drainage systems designed for medical use.
The company’s devices are regulated under FDA Class I and Class II classifications, with records supported by 510(k) submissions. Products are listed in the FDA’s regulatory database, and the manufacturer is based in the United States.
Catalogue
Mensink-Goosen Catheter Ref K844889
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Goosen Self-Lubricating Catheter Ref K923848
Regimes: 510(k) Registry: 510(k)Goosen Urinary Drainage System Ref K896579
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Goosen Enterprises, Inc. have in the registry?
The registry currently lists 4 devices for Goosen Enterprises, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Goosen Enterprises, Inc.'s devices?
Among its 4 most recently registered devices, Goosen Enterprises, Inc. has devices listed in FDA 510(k) (4 devices).
What risk classes do Goosen Enterprises, Inc.'s devices fall under?
Among its 4 most recently registered devices, the classes recorded for Goosen Enterprises, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Goosen Enterprises, Inc. in the registry?
The most recently registered devices listed for Goosen Enterprises, Inc. include MENSINK-GOOSEN CATHETER, ACUFLO, VACUUM-POWERED BODY FLUID SUCTION APPARA., GOOSEN SELF-LUBRICATING CATHETER and GOOSEN URINARY DRAINAGE SYSTEM.