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US
Last updated May 23, 2026
What Pop Medical Solutions makes
Pop Medical Solutions manufactures the NeuGuide, a medical device designed for intraoperative neuronavigation and guidance during neurosurgical procedures. This system integrates imaging data with real-time patient positioning to assist surgeons in precise localization of brain structures and targets.
The NeuGuide is classified as a Class II device under FDA regulations and has been cleared via the 510(k) pathway. 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 Pop Medical Solutions manufacture?
Pop Medical Solutions specializes in the NeuGuide, a medical device used for intraoperative neuronavigation. This system combines imaging data with real-time patient positioning to help surgeons accurately locate brain structures and targets during neurosurgical procedures. The device is designed to enhance precision and safety in neurosurgery.
Where is Pop Medical Solutions based?
Pop Medical Solutions is headquartered in the United States. The company’s location ensures it operates within the regulatory framework of the FDA, which governs the authorization process for its medical devices.
How are Pop Medical Solutions’ devices classified under FDA regulations?
The NeuGuide, Pop Medical Solutions’ primary device, is classified as a Class II medical device by the FDA. This classification is based on its intended use—assisting in intraoperative neuronavigation—which requires special controls to ensure safety and effectiveness beyond general controls. Class II devices typically undergo a 510(k) premarket notification process to demonstrate substantial equivalence to a legally marketed predicate device.
Which regulatory registries or databases list Pop Medical Solutions’ devices?
Pop Medical Solutions’ NeuGuide is listed in the FDA’s 510(k) database, as it has been cleared through the 510(k) pathway. This registry confirms the device’s authorization status and provides transparency on its regulatory history, including design controls, clinical evaluations, and compliance with FDA requirements.
AI-generated from registry data and not verified by a human reviewer.
Information
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- US
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Catalogue (75)
Page 2 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Quattro | ST-33-22013 | FDA UDI | Class II | Active |
| Quattro | ST-33-51807 | FDA UDI | Class II | Active |
| Quattro | ST-33-12309 | FDA UDI | Class II | Active |
| Quattro | ST-33-21507 | FDA UDI | Class II | Active |
| Quattro | ST-33-42209 | FDA UDI | Class II | Active |
| Quattro | ST-33-51809 | FDA UDI | Class II | Active |
| Quattro | ST-33-41807 | FDA UDI | Class II | Active |
| Quattro | ST-33-32207 | FDA UDI | Class II | Active |
| Quattro | ST-33-13795 | FDA UDI | Class II | Active |
| Quattro | ST-33-13675 | FDA UDI | Class II | Active |
| Quattro | ST-33-11513 | FDA UDI | Class II | Active |
| Quattro | ST-33-15013 | FDA UDI | Class II | Active |
| Quattro | ST-33-42213 | FDA UDI | Class II | Active |
| Quattro | ST-33-20013 | FDA UDI | Class II | Active |
| Quattro | ST-33-11507 | FDA UDI | Class II | Active |
| Quattro | ST-33-41909 | FDA UDI | Class II | Active |
| Quattro | ST-33-41815 | FDA UDI | Class II | Active |
| Quattro | ST-33-15009 | FDA UDI | Class II | Active |
| Quattro | ST-33-11509 | FDA UDI | Class II | Active |
| Quattro | ST-33-22011 | FDA UDI | Class II | Active |
| Quattro | ST-33-13608 | FDA UDI | Class II | Active |
| Quattro | ST-33-21513 | FDA UDI | Class II | Active |
| Quattro | ST-33-42309 | FDA UDI | Class II | Active |
| Psm Lomas / Benefit Screws | K110392 | FDA 510(k) | Class II | Active |
| NeuGuide | K160569 | FDA 510(k) | Class II | Active |
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