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Sign in to claim this brandScion Medical Technologies, LLC
US
Last updated May 23, 2026
What Scion Medical Technologies, LLC makes
Scion Medical Technologies, LLC makes tissue markers and core biopsy systems, including the Beacon Tissue Marker, Beacon Tissue Marker (SE), Star Tissue Marker, and the CASSI II Rotational Core Biopsy System with associated disposable components like the CASSI Quadpoint Disposable.
These devices are classified as Class II medical devices and are listed in the FDA 510(k) registry; the company is based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Scion Medical Technologies, LLC manufacture?
Scion Medical Technologies, LLC manufactures tissue markers and core biopsy systems, including the Beacon Tissue Marker, Beacon Tissue Marker (SE), Star Tissue Marker, and the CASSI II Rotational Core Biopsy System with associated disposable components such as the CASSI Quadpoint Disposable. These products are designed for use in general and plastic surgery procedures to mark tissue or obtain core biopsy samples.
Where is Scion Medical Technologies, LLC based?
Scion Medical Technologies, LLC is based in the United States, as indicated in the company's country of origin within the device data. The company operates from a location within the U.S., though no specific city or state is provided in the available information.
In which regulatory registry are Scion Medical Technologies, LLC's devices listed?
The devices manufactured by Scion Medical Technologies, LLC are listed in the FDA 510(k) registry, which is a U.S. Food and Drug Administration database for medical devices that have received clearance through the 510(k) premarket notification process. This listing indicates that the company's devices have been submitted for and received clearance under this pathway.
How are Scion Medical Technologies, LLC's devices classified under medical device regulations?
Scion Medical Technologies, LLC's devices are classified as Class II medical devices. This classification indicates that they pose moderate risk and require special controls to ensure safety and effectiveness, such as performance standards, post-market surveillance, and specific labeling requirements, as defined by the FDA's regulatory framework for medical devices.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
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Catalogue (12)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Beacon | BM1412-50-1 | FDA UDI | Class II | Active |
| Cassi | CS-2001-CC-10 | FDA UDI | Class II | Active |
| Cassi | CS2001-BH | FDA UDI | Class II | Active |
| Cassi | CS2120-NT-1 | FDA UDI | Class II | Active |
| Beacon | BM1412-50-F-1 | FDA UDI | Class II | Active |
| Cassi | CS2100-NT-1 | FDA UDI | Class II | Active |
| Beacon Tissue Marker | K130763 | FDA 510(k) | Class II | Active |
| CASSI II Rotational Core Biopsy System | K161234 | FDA 510(k) | Class II | Active |
| Beacon Tissue Marker (SE) | K153189 | FDA 510(k) | Class II | Active |
| Cassi Ii Rotational Core Biopsy System; Cassi Quadpoint Disposable | K123606 | FDA 510(k) | Class II | Active |
| Star Tissue Marker | K170905 | FDA 510(k) | Class II | Active |
| General And Plastic Surgery | K140835 | FDA 510(k) | Class II | Active |
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