The S. F. Group, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
What The S. F. Group, Inc. makes
The S. F. Group, Inc. manufactures DURASIL, a silicone-based material used for medical device modifications and components, including implants and prosthetics. The product is designed for durability and biocompatibility in long-term medical applications.
DURASIL modifications and devices fall under FDA Class I regulation, requiring 510(k) clearance for modifications. The company’s products are listed in the FDA’s 510(k) database, adhering to U.S. medical device compliance standards.
Catalogue
Durasil (Modification) Ref K961410
Regimes: 510(k) Registry: 510(k)Durasil Ref K952612
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does The S. F. Group, Inc. have in the registry?
The registry currently lists 2 devices for The S. F. Group, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list The S. F. Group, Inc.'s devices?
Among its 2 most recently registered devices, The S. F. Group, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do The S. F. Group, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for The S. F. Group, Inc.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from The S. F. Group, Inc. in the registry?
The most recently registered devices listed for The S. F. Group, Inc. include DURASIL (MODIFICATION) and DURASIL.