Integra Neurocare, LLC: FDA clearances and approvals
Integra Neurocare, LLC has 12 FDA 510(k) clearances (first 1996, latest 2000), across 4 product codes in 3 review panels. Median 510(k) review time: 88 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| JXG | Shunt, Central Nervous System And Components | 9 | 9 |
| DWF | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | 1 | 1 |
| GWM | Device, Monitoring, Intracranial Pressure | 1 | 1 |
| OCV | Endoscope Holder | 1 | 1 |
Review panels
- Neurology (10)
- Cardiovascular (1)
- Gastroenterology and Urology (1)
Most recent Integra Neurocare, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K002392 | VENTRIX TRUE TECH VENTRICULAR TUNNELING PRESSURE MONITORING KIT, MODEL NL960-V | GWM | 2000-11-02 | 87 |
| K992006 | NEUROVIEW INSTRUMENT HOLDER, MODEL 300-33 | OCV | 1999-08-17 | 63 |
| K981246 | BEVERLY REFERENTIAL VALVE (NL850-9710) WITH INTEGRAL PERITONEAL CATHETER (NL850-9720) VALVE KIT (NL850-9730) | JXG | 1999-05-26 | 415 |
| K973525 | MAURICE WORLDWIDE SHUNT SYSTEM | JXG | 1997-12-16 | 90 |
| K972994 | EXTERNAL CSF DRAINAGE MANAGEMENT SYSTEMS | JXG | 1997-11-03 | 83 |
| K972261 | RIVETTI-LEVINSON INSTRALUMINAL SHUNT | DWF | 1997-09-15 | 90 |
| K971617 | ENDOSCOPIC VENTRICULAR CATHETER | JXG | 1997-07-31 | 90 |
| K970983 | PERITONEAL/CARDIAC CATHETER | JXG | 1997-06-13 | 87 |
| K970658 | LUMBAR DRAINAGE ACCESSORY KIT | JXG | 1997-05-19 | 87 |
| K964371 | SHUNT TAP WITH ICP MONITORING ACCESS PORT | JXG | 1997-01-31 | 91 |
2 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Integra Neurocare, LLC.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Integra Neurocare, LLC have?
Integra Neurocare, LLC has 12 FDA 510(k) clearances (first 1996, latest 2000), across 4 product codes in 3 review panels.
How long does FDA take to clear Integra Neurocare, LLC's 510(k)s?
The median time from FDA receipt to decision across Integra Neurocare, LLC's cleared 510(k)s is 88 days.
What devices does Integra Neurocare, LLC make?
Its most frequent FDA product codes are JXG (Shunt, Central Nervous System And Components, 9); DWF (Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass, 1); GWM (Device, Monitoring, Intracranial Pressure, 1).
Has Integra Neurocare, LLC had device recalls?
openFDA lists no recalls under a recalling firm name matching Integra Neurocare, LLC. Related entities may recall under other names.
Next steps
- See all 12 Integra Neurocare, LLC clearances with predicates and recalls
- Run predicate analysis for product code JXG, Integra Neurocare, LLC's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.