Surgica Corp.
United StatesFDA applicant, unverified
- Devices
- 3
What Surgica Corp. makes
Surgica Corp. manufactures polyvinyl alcohol (PVA) foam embolization particles for vascular occlusion, including sizes tailored for microvascular, standard, and larger vessel applications. These particles are designed to block blood flow in targeted areas, such as during embolization procedures for tumors, arteriovenous malformations, or vascular anomalies.
The company’s embolization particles are classified as Class II medical devices under FDA regulations and are supported by 510(k) clearance in the United States. The portfolio is not listed in other major regulatory registries.
Catalogue
Maxistat Pva Foam Embolization Particles Ref K020033
Regimes: 510(k) Registry: 510(k)Pva Foam Embolization Particles Ref K001678
Regimes: 510(k) Registry: 510(k)Microstat Pva Foam Embolization Particles Ref K032619
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Surgica Corp. have in the registry?
The registry currently lists 3 devices for Surgica Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Surgica Corp.'s devices?
Among its 3 most recently registered devices, Surgica Corp. has devices listed in FDA 510(k) (3 devices).
What risk classes do Surgica Corp.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Surgica Corp.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Surgica Corp. in the registry?
The most recently registered devices listed for Surgica Corp. include MAXISTAT PVA FOAM EMBOLIZATION PARTICLES, PVA FOAM EMBOLIZATION PARTICLES and MICROSTAT PVA FOAM EMBOLIZATION PARTICLES.