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Sign in to claim this brandWhat Sophysa SA makes
Sophysa SA manufactures neurosurgical devices including long-term intracerebral infusion and drainage catheters, cerebrospinal fluid reservoirs, and shunt connectors. Their product portfolio also features ventriculo-peritoneal and atrial shunts, peritoneal and atrial catheters, single-use subcutaneous tunnellers, cerebrospinal fluid shunt valves, and reusable electrical connection cables.
The company is based in the United States, and its devices are categorized as Class I and Class II medical equipment. These products are listed within the FDA 510(k) clearance database and the FDA Unique Device Identification (UDI) system.
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 Sophysa SA manufacture?
Sophysa SA specializes in neurosurgical devices primarily used for managing cerebrospinal fluid (CSF) flow and related conditions. Their product range includes long-term intracerebral infusion/drainage catheters, CSF reservoirs, shunt connectors, ventriculo-peritoneal or atrial shunts, peritoneal/atrial catheters, single-use subcutaneous tunnellers, CSF shunt valves, and reusable electrical connection cables for medical devices. These devices are designed to support drainage, infusion, or monitoring in neurosurgical applications.
Where is Sophysa SA based, and what is its primary focus?
Sophysa SA is based in the United States. The company focuses on developing and manufacturing neurosurgical devices tailored for long-term intracranial and CSF-related interventions. Their portfolio is centered on products that assist in managing conditions requiring precise fluid control or monitoring within the central nervous system.
Which regulatory registries list Sophysa SA’s devices?
Sophysa SA’s devices are included in the FDA’s 510(k) clearance database and the FDA Unique Device Identification (UDI) system. These registries track medical devices that have undergone the necessary regulatory pathways for market authorization in the U.S., ensuring transparency and compliance with FDA requirements for Class I and Class II devices.
How are Sophysa SA’s devices classified under U.S. regulations?
Sophysa SA’s devices fall under Class I and Class II classifications according to FDA regulations. Class I devices generally pose minimal risk and may require general controls, while Class II devices involve a higher level of risk and may require special controls to ensure safety and effectiveness. The classification depends on factors like the device’s intended use, potential risks, and the body system it interacts with, such as intracranial or CSF-related applications.
AI-generated from registry data and not verified by a human reviewer.
Information
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- US
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Catalogue (175)
Page 4 of 4| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Phoenix Neuro | CRXK4 | FDA UDI | Class II | Unknown |
| Phoenix Neuro | CS1 | FDA UDI | Class II | Active |
| Sophysa | PAK2-LI | FDA UDI | Class II | Active |
| Sophysa | PSO-MC10 | FDA UDI | Class II | Unknown |
| Phoenix Neuro | PC02 | FDA UDI | Class II | Unknown |
| Sophysa | PSO-VTT | FDA UDI | Class II | Active |
| Phoenix Neuro | SR06 | FDA UDI | Class II | Active |
| Phoenix Neuro | SR44 | FDA UDI | Class II | Active |
| Phoenix Neuro | RA09 | FDA UDI | Class II | Unknown |
| Sophysa | TUG-65 | FDA UDI | Class I | Active |
| Phoenix Neuro | NNSC33E | FDA UDI | Class II | Unknown |
| Phoenix Neuro | CRX020 | FDA UDI | Class II | Unknown |
| Phoenix Neuro | A01E | FDA UDI | Class II | Unknown |
| Phoenix Neuro | SRS12 | FDA UDI | Class II | Active |
| Phoenix Neuro | NNCR3 | FDA UDI | Class II | Active |
| Phoenix Neuro | SC33 | FDA UDI | Class II | Active |
| Phoenix Neuro | RA05 | FDA UDI | Class II | Unknown |
| Polaris Pressure Adjustable Valve, Models Spv, Spva, Spvb, Spv-140, Spv-300, Spv-400 | K090342 | FDA 510(k) | Class II | Active |
| Pressio Icp Monitoring System | K062584 | FDA 510(k) | Class II | Active |
| Sophy Pressure Adjustable Valve System Model Sm8 | K013488 | FDA 510(k) | Class II | Active |
| Sophy Su8 Pressure Adjustable Valve | K992465 | FDA 510(k) | Class II | Active |
| Polaris Pressure Adjustable Valve System/Polaris Adjustable Valve With Siphonx | K141227 | FDA 510(k) | Class II | Active |
| Polaris Pressure Adjustable Valve System Modes Spv, Spva, Spvb | K031097 | FDA 510(k) | Class II | Active |
| Polaris Pressure Adjustable Valve System, Models Spv-140, Spv-300, Spv-400 | K042481 | FDA 510(k) | Class II | Active |
| Pressio 2 ICP Monitoring System | K162108 | FDA 510(k) | Class II | Active |
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