Prostec, LLC
United StatesFDA applicant, unverified
- Devices
- 2
What Prostec, LLC makes
Prostec, LLC manufactures radioactive brachytherapy seeds and snapseed devices for internal radiation therapy, specifically designed for use with iodine-125 (125I) sources. These products are intended for localized treatment in medical procedures such as prostate brachytherapy.
The company’s devices are classified under FDA Class II and are subject to 510(k) clearance in the United States. The portfolio is regulated under US medical device laws, with listings maintained in the FDA’s 510(k) database.
Catalogue
Prostec 125I Branchytherapy Snapseed Ref K001366
Regimes: 510(k) Registry: 510(k)Prostec 125I Brachytherapy Seeds Ref K993280
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Prostec, LLC have in the registry?
The registry currently lists 2 devices for Prostec, LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list Prostec, LLC's devices?
Among its 2 most recently registered devices, Prostec, LLC has devices listed in FDA 510(k) (2 devices).
What risk classes do Prostec, LLC's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Prostec, LLC's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Prostec, LLC in the registry?
The most recently registered devices listed for Prostec, LLC include PROSTEC 125I BRANCHYTHERAPY SNAPSEED and PROSTEC 125I BRACHYTHERAPY SEEDS.