Roland J. Zwick, Inc.
United StatesFDA 510(k) applicant, unverified
- Devices
- 2
What Roland J. Zwick, Inc. makes
Roland J. Zwick, Inc. manufactures single-use urinary catheters (DISPO-URETTE) and devices for measuring tissue shear strength (CIN-SHEAR), used primarily in clinical and research settings.
The company’s products are regulated under FDA Class I and Class II classifications, with some devices requiring 510(k) clearance. These devices are listed in the FDA’s 510(k) database. The manufacturer is based in the United States.
Catalogue
Dispo-Urette Ref K860796
510(k) 510(k)Cin-Shear Ref K840352
510(k) 510(k)
Frequently asked questions
How many devices does Roland J. Zwick, Inc. have in the registry?
The registry currently lists 2 devices for Roland J. Zwick, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Roland J. Zwick, Inc.'s devices?
Among its 2 most recently registered devices, Roland J. Zwick, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Roland J. Zwick, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Roland J. Zwick, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Roland J. Zwick, Inc. in the registry?
The most recently registered devices listed for Roland J. Zwick, Inc. include DISPO-URETTE and CIN-SHEAR.