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Sign in to claim this brandUS MEDICAL INNOVATIONS, LLC
US
Last updated May 25, 2026
What US MEDICAL INNOVATIONS, LLC makes
US Medical Innovations, LLC manufactures electrosurgical devices designed for both endoscopic and open-surgery applications, including single-use and reusable inert gas-enhanced electrodes, as well as electrosurgical systems and generators. Their portfolio includes probes, handpieces, ablation systems, and hybrid plasma tools tailored for precision tissue treatment, such as the Canady Plasma GIT probes, Helios Cold Plasma Ablator, and Hybrid Plasma Paddle Blade. The company also produces electrosurgical generators like the SMART XL-1000 series, which integrate with accessory probes and blades for surgical procedures. These devices are intended for controlled tissue manipulation, coagulation, and ablation in medical settings.
The company’s products fall under Class II regulatory classification in the US, requiring premarket notification (510(k)) submissions and compliance with the FDA’s Unique Device Identification (UDI) system. Devices are listed in the FDA’s 510(k) and UDI registries, ensuring traceability and adherence to US medical device regulations. The manufacturer operates from the United States, where its portfolio is subject to FDA oversight and compliance requirements.
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 US Medical Innovations, LLC manufacture?
US Medical Innovations, LLC specializes in electrosurgical devices used in both endoscopic and open-surgery procedures. Their portfolio includes inert gas-enhanced electrodes (single-use and reusable), electrosurgical systems, and generators like the Canady Plasma GIT probes, Helios Cold Plasma Ablator, and SMART XL-1000 series. These tools are designed for precision tissue treatment, such as coagulation, ablation, and controlled manipulation during surgery.
Where is US Medical Innovations, LLC based, and how does that affect its devices?
US Medical Innovations, LLC is based in the United States, meaning its devices are subject to FDA regulatory oversight. The company’s products are classified under Class II, requiring compliance with FDA’s premarket notification (510(k)) process and Unique Device Identification (UDI) system. This ensures traceability and adherence to US medical device regulations.
Which regulatory registries list US Medical Innovations, LLC’s devices?
The company’s devices are listed in the FDA’s 510(k) and UDI registries. The 510(k) submission process is required for Class II devices to demonstrate substantial equivalence to a predicate, while the UDI system ensures each device has a unique identifier for tracking and compliance purposes.
How are US Medical Innovations, LLC’s devices classified under US regulations?
All of US Medical Innovations, LLC’s devices fall under the Class II regulatory classification in the US. This classification requires manufacturers to submit a premarket notification (510(k)) to the FDA to demonstrate that their device is at least as safe and effective as a legally marketed predicate device. Class II devices also require compliance with FDA’s UDI system for better tracking and post-market surveillance.
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
- 961656951
Catalogue (19)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Protecta-Gel® | JRJ 41501SM | FDA UDI | Class I | Active |
| Canady Hybrid Plasma Scalpel | AW-422554 | FDA UDI | Class II | Unknown |
| Canady Plasma GIT Probe | AW-422538 | FDA UDI | Class II | Active |
| SeeFactorCT3 | SeeFactorCT3 | FDA UDI | Class II | Unknown |
| Protecta-Gel® | JRJ 41501 | FDA UDI | Class I | Active |
| Canady Plasma GIT Side Fire Probe | AW-422541 | FDA UDI | Class II | Active |
| SeeFactor CT3 | 9801101000 | FDA UDI | Class II | Unknown |
| US Medical Innovations | XL-1000 | FDA UDI | Class II | Active |
| Stoma-Gel™ | JRJ 42501 | FDA UDI | Class I | Active |
| Canady Helios Cold Plasma Ablator Handpiece (Handle + 85mm) | CP-41110 | FDA UDI | Class II | Active |
| US Medical Innovations | XL-1000CP | FDA UDI | Class II | Active |
| Canady Hybrid Plasma Paddle Blade | PB-422555 | FDA UDI | Class II | Active |
| Canady Hybrid Plasma Scalpel | AW-422552 | FDA UDI | Class II | Unknown |
| Canady Plasma GIT Side Fire Probe | AW-422540 | FDA UDI | Class II | Active |
| Canady Plasma SMART XL-1000 Electrosurgical Generator with Accessories | K192124 | FDA 510(k) | Class II | Active |
| Canady Vieira Hybrid Plasma Scalpel | K113500 | FDA 510(k) | Class II | Active |
| Canady Plasma Electrosurgical Unit Series With Accessory Probes And Blades | K100669 | FDA 510(k) | Class II | Active |
| Canady Helios Cold Plasma™ XL-1000CP™ Ablation System (XL-1000CPSYS) | K240297 | FDA 510(k) | Class II | Active |
| Canady Flex RoboWrist | K212736 | FDA 510(k) | Class II | Active |
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