Integra Neurosciences: FDA clearances and approvals
Integra Neurosciences has 9 FDA 510(k) clearances (first 2000, latest 2008), across 4 product codes in 2 review panels. Median 510(k) review time: 37 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 |
|---|---|---|---|
| GWM | Device, Monitoring, Intracranial Pressure | 5 | 5 |
| LFL | Instrument, Ultrasonic Surgical | 2 | 2 |
| GYC | Electrode, Cortical | 1 | 1 |
| JXG | Shunt, Central Nervous System And Components | 1 | 1 |
Review panels
Most recent Integra Neurosciences 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K082250 | AURAGEN CORTICAL SURFACE ELECTRODES | GYC | 2008-10-10 | 63 |
| K050720 | NEUROSENSOR CEREBRAL BLOOD FLOW AND INTRACRANIAL PRESSURE MONITORING KIT/SYSTEM, MODELS NS-P, NS-100 | GWM | 2005-05-11 | 51 |
| K042277 | SELECTOR QUANTUM ULTRASONIC ASPIRATOR SYSTEM | LFL | 2004-09-29 | 37 |
| K031086 | CAMINO SINGLE PARAMETER MONITOR, MODEL SPM-1 | GWM | 2003-05-14 | 37 |
| K021989 | SELECTOR INTEGRA ULTRASONIC SURGICAL ASPIRATOR, MODEL OM 1530000M3 | LFL | 2002-09-13 | 87 |
| K022554 | MONITORR ICP EXTERNAL CSF DRAINAGE AND MONITORING SYSTEM | JXG | 2002-08-23 | 21 |
| K022553 | CAMINO INTRACRANIAL PRESSURE MONITORING CATHETER WITH LICOX IMC BOLT FITTING, MODEL 110-4L | GWM | 2002-08-20 | 18 |
| K020558 | LICOX CC1.G2 BRAIN OXYGEN CATHETER-MICROPROBE | GWM | 2002-03-21 | 29 |
| K002765 | LICOX CMP MONITOR-AC3.1, LICOX IMC OXYGEN CATHETERS-CC1,CC1.SB LUICOX IMC INTRODUCER KITS-IM,IM2,IM3,II1 LICOXIMC TEMPE | GWM | 2000-11-24 | 80 |
Recalls
openFDA lists no recalls under a recalling firm named Integra Neurosciences.
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 Neurosciences have?
Integra Neurosciences has 9 FDA 510(k) clearances (first 2000, latest 2008), across 4 product codes in 2 review panels.
How long does FDA take to clear Integra Neurosciences's 510(k)s?
The median time from FDA receipt to decision across Integra Neurosciences's cleared 510(k)s is 37 days.
What devices does Integra Neurosciences make?
Its most frequent FDA product codes are GWM (Device, Monitoring, Intracranial Pressure, 5); LFL (Instrument, Ultrasonic Surgical, 2); GYC (Electrode, Cortical, 1).
Has Integra Neurosciences had device recalls?
openFDA lists no recalls under a recalling firm name matching Integra Neurosciences. Related entities may recall under other names.
Next steps
- See all 9 Integra Neurosciences clearances with predicates and recalls
- Run predicate analysis for product code GWM, Integra Neurosciences'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.