Neuropace, Inc.
United StatesFDA applicant, unverified
Neuropace, Inc. is a medical device manufacturer, with 39 devices listed in FDA GUDID, FDA 510(k) and FDA PMA (FDA Class III and II) as of 14 Nov 2026.
- Devices
- 39
Registry facts
- Registries
- FDA GUDID 36
- FDA 510(k) 2
- FDA PMA 1
- Device classes
- FDA Class III 36
- FDA Class II 3
- Identifiers
- DUNS 123369238
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.
Catalogue
Search and filter all 39 devicesCompany details
- DUNS number
- 123369238
- Phone
- +1(866)726-3876
Frequently asked questions
How many devices does Neuropace, Inc. have in the registry?
The registry currently lists 39 devices for Neuropace, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Neuropace, Inc.'s devices?
Among its 39 most recently registered devices, Neuropace, Inc. has devices listed in FDA 510(k) (2 devices), FDA PMA (1 device) and FDA GUDID (36 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Neuropace, Inc.'s devices fall under?
Among its 39 most recently registered devices, the classes recorded for Neuropace, Inc.'s devices are Class II and Class III. Each device page shows its own class and authorisation.
What are the newest devices from Neuropace, Inc. in the registry?
The most recently registered devices listed for Neuropace, Inc. include NeuroPace® Depth Lead Kit DL-330-10-K, NeuroPace® Cortical Strip Lead Kit CL-335-10-K, NeuroPace® Programmer Kit PGM-300-K and Explant Kit EX-01-K.