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Sign in to claim this brandIon Medical, LLC
US
Last updated May 23, 2026
What Ion Medical, LLC makes
Ion Medical, LLC manufactures single-use, bipolar endoscopic electrosurgical handpieces and electrodes designed for tissue coagulation during minimally invasive procedures. The devices are intended for use in surgical settings where precise control of coagulation is required, such as in endoscopic surgeries.
The company’s portfolio consists of Class II medical devices, regulated under FDA pathways including the 510(k) premarket notification process and the Unique Device Identification (UDI) system. These devices are listed in the FDA’s regulatory databases for compliance tracking.
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 Ion Medical, LLC manufacture?
Ion Medical, LLC specializes in single-use, bipolar endoscopic electrosurgical handpieces and electrodes. These devices are specifically designed for tissue coagulation during minimally invasive surgeries, such as endoscopic procedures, where precise control of coagulation is essential. The focus is on Class II devices, which are regulated under stricter controls due to their intended use in critical surgical applications.
Where is Ion Medical, LLC based?
Ion Medical, LLC is headquartered in the United States. The company’s location influences its regulatory compliance with FDA requirements, including device classification, premarket submissions, and UDI implementation for its products.
Which regulatory registries or databases list Ion Medical, LLC’s devices?
Ion Medical, LLC’s devices are listed in the FDA’s regulatory databases, specifically under the 510(k) premarket notification process and the Unique Device Identification (UDI) system. These registries ensure compliance tracking and transparency for authorized devices, which are classified as Class II under FDA guidelines.
How are Ion Medical, LLC’s devices classified under FDA regulations?
Ion Medical, LLC’s devices fall under Class II classification by the FDA. This classification applies to devices that pose moderate risk and require special controls beyond general controls to ensure safety and effectiveness. The company’s products, such as bipolar coagulation handpieces, are subject to premarket submissions (e.g., 510(k)) and ongoing compliance with UDI requirements to maintain authorization.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
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Catalogue (9)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Ion Coagulation Pen | 202316 | FDA UDI | Class II | Active |
| Ion Coagulation Pen | 202010 | FDA UDI | Class II | Active |
| Ion Coagulation Pen | 202310 | FDA UDI | Class II | Active |
| Ion Coagulation Pen | 202730 | FDA UDI | Class II | Active |
| Ion Coagulation Pen | 202315 | FDA UDI | Class II | Active |
| Ion Coagulation Pen | 202530 | FDA UDI | Class II | Active |
| Ion Coagulation Pen | 201850 | FDA UDI | Class II | Active |
| Ion Coagulation Pen | 201860 | FDA UDI | Class II | Active |
| Ion Medical Bipolar Coagulation Pen | K072911 | FDA 510(k) | Class II | Active |
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