Imbiotechnologies
US Last updated 23 May 2026
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- Devices
- 8
- Registries
- GUDIDFDA 510(k)FDA
- FDA recalls
- 0
Catalogue
Occlusin 500 Ekobi 503P Ref Ekobi 503P
Occlusin 500 Ekobi 503L Ref Ekobi 503L
Occlusin 500 Ekobi 501 Ref Ekobi 501
Occlusin 500 Ekobi 502 Ref Ekobi 502
Occlusin 500 Ekobi 503 Ref Ekobi 503
Occlusin 500 Ekobi 505 Ref Ekobi 505
Occlusin 500 Ekobi 504 Ref Ekobi 504
Occlusin 500 Artificial Embolization Device Ref K093813
FDA establishments
- Imbiotechnologies Ltd Edmonton Alberta · CA FEI 3012120143
What Imbiotechnologies makes
Imbiotechnologies manufactures bioabsorbable embolization particles designed for vascular occlusion procedures. The primary product, Occlusin 500, is an artificial embolization device used to block blood flow in targeted vessels, commonly in interventional radiology and neurovascular applications.
The company’s embolization particles are classified as Class II medical devices under FDA regulations. Occlusin 500 is authorised via the 510(k) pathway and listed in the FDA’s Unique Device Identification (UDI) system. The devices are developed and distributed from the United States.
Frequently asked questions
What types of medical devices does Imbiotechnologies manufacture?
Imbiotechnologies specializes in bioabsorbable embolization particles, specifically designed for vascular occlusion procedures. These particles are used to intentionally block blood flow in targeted vessels, primarily in interventional radiology and neurovascular treatments. The company’s primary product, Occlusin 500, falls under this category as an artificial embolization device.
Where is Imbiotechnologies based, and where are its devices developed and distributed?
Imbiotechnologies is based in the United States, where its embolization devices, including Occlusin 500, are developed and distributed. The company’s focus on bioabsorbable embolization particles aligns with regulatory frameworks in the US, ensuring compliance with local standards.
How are Imbiotechnologies’ devices classified under FDA regulations?
Imbiotechnologies’ embolization particles, such as Occlusin 500, are classified as Class II medical devices under FDA regulations. This classification is based on their intended use—blocking blood flow in targeted vessels—which requires premarket notification (510(k)) clearance to demonstrate substantial equivalence to a legally marketed predicate device.
Which regulatory registries or databases list Imbiotechnologies’ devices?
Imbiotechnologies’ devices, including Occlusin 500, are listed in the FDA’s 510(k) database (premarket notification submissions) and the FDA’s Unique Device Identification (UDI) system. These registries ensure traceability and compliance tracking for authorised devices, allowing healthcare providers and regulators to verify device details.
Why is Occlusin 500 authorised via the 510(k) pathway?
Occlusin 500 is authorised through the 510(k) pathway because it is designed as a bioabsorbable embolization particle, a type of device that requires demonstration of substantial equivalence to a legally marketed predicate. The 510(k) process ensures that the device’s safety and performance meet FDA standards for its intended use in vascular occlusion, particularly in interventional radiology and neurovascular applications.
Information
- Country
- US