Biocure, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
What Biocure, Inc. makes
Biocure, Inc. manufactures the GELSPRAY WOUND DRESSING, a topical application for wound care, and the GELSPHERES EMBOLIC AGENT, a microsphere-based solution for embolization procedures.
The company’s products are regulated under FDA’s 510(k) pathway, with the GELSPRAY WOUND DRESSING classified as Class I and the GELSPHERES EMBOLIC AGENT as Class II. Both devices are listed in the FDA’s 510(k) clearance registry.
Catalogue
Gelspray Wound Dressing Ref K073663
Regimes: 510(k) Registry: 510(k)Gelspheres Embolic Agent Ref K023089
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Biocure, Inc. have in the registry?
The registry currently lists 2 devices for Biocure, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Biocure, Inc.'s devices?
Among its 2 most recently registered devices, Biocure, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Biocure, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Biocure, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Biocure, Inc. in the registry?
The most recently registered devices listed for Biocure, Inc. include GELSPRAY WOUND DRESSING and GELSPHERES EMBOLIC AGENT.