FDA applicant
Integra Neurocare, LLC
FDA records 12 decisions for Integra Neurocare, LLC (Pleasant Prairie, WI) from 1996 to 2000: 12 510(k) clearances. Most are in product codes JXG (Shunt, Central Nervous System And Components) and OCV (Endoscope Holder). Its devices cite 5 predicates, 0 of them its own earlier devices. No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Integra Neurocare, LLC’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Integra Neurocare, LLC since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Integra Neurocare, LLC’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) ReportOther applicant names beginning “Integra”
FDA records each applicant name separately; these may or may not be the same firm.