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Sign in to claim this brandNeuropace, Inc.
US
Last updated May 24, 2026
What Neuropace, Inc. makes
Neuropace, Inc. manufactures brain-responsive electrical stimulation systems, including depth leads, cortical strip leads, and neurostimulator kits designed for deep brain monitoring and stimulation. The company also produces active implantable device control magnets, reusable cannulated surgical drill bits, cranial bur hole covers, and non-bioabsorbable craniofacial fixation plates for cranial procedures. Additional offerings include surgical templates, connector covers, and remote monitoring kits for post-implant patient tracking.
The company’s portfolio is regulated under both Class II and Class III medical device classifications in the US, with devices authorised through FDA pathways including 510(k), PMA, and UDI submissions. These products are listed in the FDA’s regulatory databases, and the manufacturer operates from 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 Neuropace, Inc. primarily manufacture?
Neuropace, Inc. specializes in brain-responsive electrical stimulation systems, including depth leads and cortical strip leads for deep brain monitoring and stimulation. Their portfolio also includes active implantable device control magnets, reusable surgical tools like cannulated drill bits, cranial bur hole covers, and non-bioabsorbable craniofacial fixation plates. These devices are designed for neurosurgical and neurostimulation applications, with a focus on implantable and monitoring solutions.
Where is Neuropace, Inc. based, and what does that mean for its regulatory oversight?
Neuropace, Inc. is based in the United States, which means its devices are subject to FDA regulatory oversight. The company’s products fall under both Class II and Class III classifications, indicating varying levels of risk and regulatory scrutiny. Class III devices, in particular, often require more rigorous authorization pathways like Premarket Approval (PMA) due to higher risk, while Class II devices may follow the 510(k) pathway if they are substantially equivalent to existing authorised devices.
Which regulatory registries or databases list Neuropace, Inc.’s devices?
Neuropace, Inc.’s devices are listed in the FDA’s regulatory databases, including the 510(k) clearance registry, Premarket Approval (PMA) submissions, and the Unique Device Identifier (UDI) database. These registries track authorised devices and their compliance with FDA requirements, ensuring transparency for healthcare providers and regulators. The company’s products are authorised through these pathways, which are publicly accessible for reference.
How are Neuropace, Inc.’s devices classified under FDA regulations?
Neuropace, Inc.’s devices are classified under both Class II and Class III categories by the FDA. Class II devices generally pose moderate risk and may require special controls beyond general controls, such as performance standards or post-market surveillance. Class III devices, which include certain neurostimulation and implantable systems, are classified as high-risk and typically require Premarket Approval (PMA) due to insufficient data from less stringent pathways, ensuring their safety and effectiveness before market authorisation.
What types of surgical and monitoring tools does Neuropace, Inc. provide alongside its neurostimulation devices?
Beyond neurostimulation devices like leads and neurostimulators, Neuropace, Inc. offers surgical tools such as reusable cannulated drill bits for precise cranial procedures, cranial bur hole covers to seal surgical sites, and craniofacial fixation plates for stabilizing cranial structures post-surgery. Additionally, the company provides surgical templates like the Craniectomy Template Kit and remote monitoring kits, such as the NeuroPace® Remote Monitor Kit, to enable post-implant patient tracking and management. These tools support both intraoperative precision and long-term patient care.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- neuropace.com
- —
- —
- [email protected]
- Phone
- +1(866)726-3876
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 123369238
Catalogue (39)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| NeuroPace® Depth Lead Kit | DL-330-10-K | FDA UDI | Class III | Active |
| NeuroPace® Cortical Strip Lead Kit | CL-335-10-K | FDA UDI | Class III | Active |
| NeuroPace® Programmer Kit | PGM-300-K | FDA UDI | Class III | Active |
| Explant Kit | EX-01-K | FDA UDI | Class III | Active |
| NeuroPace® Cortical Strip Lead Kit | CL-325-10-K | FDA UDI | Class III | Active |
| RNS® Neurostimulator Kit | RNS-300M-K | FDA UDI | Class III | Active |
| NeuroPace® Depth Lead Kit | DL-330-3.5-K | FDA UDI | Class III | Active |
| NeuroPace® Depth Lead Kit | DL-330-3.5-K | FDA UDI | Class III | Active |
| Craniectomy Template Kit | CT-01-K | FDA UDI | Class III | Active |
| Connector Cover Kit | CC-01-K | FDA UDI | Class III | Active |
| NeuroPace® Remote Monitor Kit | 5101 | FDA UDI | Class III | Active |
| RNS® Neurostimulator Kit | RNS-320-K | FDA UDI | Class III | Active |
| NeuroPace® Cortical Strip Lead Kit | CL-335-10-K | FDA UDI | Class III | Active |
| NeuroPace® Cortical Strip Lead Kit | CL-315-10-K | FDA UDI | Class III | Active |
| Remote Monitor Phone Accessories | 5104 | FDA UDI | Class III | Active |
| RNS® Tablet Kit | 5001 | FDA UDI | Class III | Active |
| Craniectomy Template Kit | CT-01-K | FDA UDI | Class III | Active |
| NeuroPace® Depth Lead Kit | DL-344-3.5-K | FDA UDI | Class III | Active |
| NeuroPace® Depth Lead Kit | DL-344-10-K | FDA UDI | Class III | Active |
| Ferrule Kit | F-01-K | FDA UDI | Class III | Active |
| NeuroPace® Remote Monitor Kit | DTR-300-E-K | FDA UDI | Class III | Active |
| Magnet | M-01 | FDA UDI | Class III | Active |
| NeuroPace® Depth Lead Kit | DL-330-10-K | FDA UDI | Class III | Active |
| NeuroPace® Depth Lead Kit | DL-344-10-K | FDA UDI | Class III | Active |
| Wand | W-02 | FDA UDI | Class III | Active |
| RNS® Neurostimulator Kit | RNS-320-K | FDA UDI | Class III | Active |
| NeuroPace® Patient Data Management System (PDMS) | Model 4340 | FDA UDI | Class III | Active |
| NeuroPace® Lead Accessory Kit | LA-02-K | FDA UDI | Class III | Active |
| Burr Hole Cover | 8110 | FDA UDI | Class II | Active |
| Ferrule Kit | F-01-K | FDA UDI | Class III | Active |
| NeuroPace® Cortical Strip Lead Kit | CL-325-10-K | FDA UDI | Class III | Active |
| NeuroPace® Cortical Strip Lead Kit | CL-315-10-K | FDA UDI | Class III | Active |
| Connector Cover Kit | CC-01-K | FDA UDI | Class III | Active |
| NeuroPace® Depth Lead Kit | DL-344-3.5-K | FDA UDI | Class III | Active |
| NeuroPace® Remote Monitor Kit | DTR-300-K | FDA UDI | Class III | Active |
| NeuroPace® Remote Monitor Kit | 5107 | FDA UDI | Class III | Active |
| Neuropace Burr Hole Cover Model 8110 | K123163 | FDA 510(k) | Class II | Active |
| Neuropace Burr Hole Cover | K141368 | FDA 510(k) | Class II | Active |
| NeuroPace RNS System | P100026 | FDA PMA | Class III | Active |
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