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Sign in to claim this brandStellar Medical, LLC
US
Last updated May 23, 2026
What Stellar Medical, LLC makes
Stellar Medical, LLC manufactures brachytherapy injection needles and implantable radiological image markers. These devices are designed for precise delivery of radioactive sources and for enhancing visibility in imaging during medical procedures.
The company’s products are classified as Class II devices under FDA regulations and are authorised via 510(k) clearances and the FDA’s Unique Device Identification (UDI) system. The devices are listed in the FDA’s regulatory databases.
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 Stellar Medical, LLC manufacture?
Stellar Medical, LLC specializes in two primary device categories: brachytherapy injection needles and implantable radiological image markers. Brachytherapy needles are used for delivering radioactive sources directly into tissue during cancer treatment, while radiological image markers enhance visibility in imaging systems to improve procedural accuracy.
Where is Stellar Medical, LLC based?
Stellar Medical, LLC is headquartered in the United States. The company’s location is relevant for regulatory oversight, as its devices are authorised under U.S. FDA guidelines.
How are Stellar Medical, LLC’s devices classified under FDA regulations?
Stellar Medical’s devices are classified as Class II under FDA regulations. This classification indicates moderate risk, requiring special controls to ensure safety and effectiveness, such as performance standards or post-market surveillance.
Which regulatory registries or databases list Stellar Medical, LLC’s devices?
Stellar Medical’s devices are listed in the FDA’s 510(k) clearance database and the Unique Device Identification (UDI) system. These registries track authorised medical devices to ensure transparency and compliance with U.S. regulatory requirements.
Why are Stellar Medical’s devices authorised via 510(k) clearances?
The 510(k) clearance process is used for Class II devices to demonstrate that a new device is substantially equivalent to a legally marketed predicate device. This pathway ensures that Stellar Medical’s products meet FDA safety and performance standards without requiring the more rigorous premarket approval process.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- Phone
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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
- 015116092
Catalogue (62)
Page 2 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Stellar Medical | 1231SM | FDA UDI | Class II | Active |
| Stellar Medical | L0834SM | FDA UDI | Class II | Active |
| Stellar Medical | 0854SM | FDA UDI | Class II | Active |
| Stellar Medical | L1251SM | FDA UDI | Class II | Active |
| Stellar Medical | 0853SM | FDA UDI | Class II | Active |
| Stellar Medical | L1055SM | FDA UDI | Class II | Active |
| Stellar Medical | 1054SM | FDA UDI | Class II | Active |
| Stellar Medical | 0451SM | FDA UDI | Class II | Active |
| Stellar Medical | 1051SM | FDA UDI | Class II | Active |
| Stellar Medical | 1253SM | FDA UDI | Class II | Active |
| Stellar Model Hs-04 | K973223 | FDA 510(k) | Class II | Active |
| Stellar Fiducial Marker, Model Gfmia | K092041 | FDA 510(k) | Class II | Active |
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