Clinical Neuro Systems, LLC
United StatesFDA applicant, unverified
- Devices
- 5
What Clinical Neuro Systems, LLC makes
Clinical Neuro Systems, LLC manufactures intracranial pressure (ICP) monitoring systems, including lumbar catheters, ventricular catheters, external CSF drain/monitoring systems, and cranial drills designed for neurosurgical procedures. Their products also include interchangeable burr bits for cranial drilling, intended for use in surgical interventions requiring precise bone removal.
The company’s devices are classified as Class II under FDA regulations and are listed via the 510(k) pathway. These products are intended for use in the United States, where they are subject to FDA oversight.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Cns Interchangeable Bit Cranial Drill Ref K961113
Regimes: 510(k) Registry: 510(k)Clinical Neuro Systems Cranial Drill Ref K930229
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Clinical Neuro Systems, LLC have in the registry?
The registry currently lists 5 devices for Clinical Neuro Systems, LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list Clinical Neuro Systems, LLC's devices?
Among its 5 most recently registered devices, Clinical Neuro Systems, LLC has devices listed in FDA 510(k) (5 devices).
What risk classes do Clinical Neuro Systems, LLC's devices fall under?
Among its 5 most recently registered devices, the classes recorded for Clinical Neuro Systems, LLC's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Clinical Neuro Systems, LLC in the registry?
The most recently registered devices listed for Clinical Neuro Systems, LLC include CLINICAL NEURO SYSTEMS MONITORR ICP LUMBAR CATHETE, CNS INTERCHANGEABLE BIT CRANIAL DRILL, CLINICAL NEURO SYSTEMS CRANIAL DRILL and CLINICAL NEURO SYSTEMS MONITORR ICP VENTRICULAR CA.