MoniTorr ICP External Drainage and Monitoring System, LimiTorr Volume Limiting External CSF Drainage System— 510(k) K191684
Substantially EquivalentIntegra LifeSciences Corporation
FDA 510(k) clearance K191684 for MoniTorr ICP External Drainage and Monitoring System, LimiTorr Volume Limiting External CSF Drainage System, Substantially Equivalent on 2019-10-11. Applicant: Integra LifeSciences Corporation. Device class: 2.
Clearance details
- Applicant
- Integra LifeSciences Corporation
- Product code
- Code JXG
- Device class
- Class 2
- Regulation
- 21 CFR 882.5550
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Planisboro, NJ, US
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Adverse events under product code JXG
product code JXG- Death
- 76
- Injury
- 5,632
- Malfunction
- 2,230
- Other
- 4
- Total
- 7,942
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.