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FDA 510(k)

MoniTorr ICP External Drainage and Monitoring System, LimiTorr Volume Limiting External CSF Drainage System

K-Number: K191684 · 2019-10-11

ApplicantIntegra LifeSciences Corporation
Decision Date2019-10-11
Product CodeJXG
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

MoniTorr ICP External Drainage and Monitoring System, LimiTorr Volume Limiting External CSF Drainage System is a medical device manufactured by Integra LifeSciences Corporation. It received FDA 510(k) clearance on 2019-10-11 under approval number K191684. The device is classified under product code JXG. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MoniTorr ICP External Drainage and Monitoring System, LimiTorr Volume Limiting External CSF Drainage System?

MoniTorr ICP External Drainage and Monitoring System, LimiTorr Volume Limiting External CSF Drainage System is a medical device that received FDA 510(k) clearance on 2019-10-11. It is manufactured by Integra LifeSciences Corporation. The 510(k) number is K191684.

When was MoniTorr ICP External Drainage and Monitoring System, LimiTorr Volume Limiting External CSF Drainage System approved by the FDA?

MoniTorr ICP External Drainage and Monitoring System, LimiTorr Volume Limiting External CSF Drainage System received FDA 510(k) clearance on 2019-10-11, under approval number K191684.

What company makes MoniTorr ICP External Drainage and Monitoring System, LimiTorr Volume Limiting External CSF Drainage System?

MoniTorr ICP External Drainage and Monitoring System, LimiTorr Volume Limiting External CSF Drainage System is manufactured by Integra LifeSciences Corporation.

What is the FDA product code for MoniTorr ICP External Drainage and Monitoring System, LimiTorr Volume Limiting External CSF Drainage System?

The FDA product code for MoniTorr ICP External Drainage and Monitoring System, LimiTorr Volume Limiting External CSF Drainage System is JXG.

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Related Devices (Code: JXG)

K162437Codman EDS3 CSF External Drainage SystemCodman & Shurtleff, Inc. K161605Smart External Drain (SED) SystemAqueduct Critical Care, Inc. K161992Horizontal-Vertical Lumbar Valve Systems, Spetzler Lumbar Peritoneal Shunt SystemsIntegra LifeSciences Corporation K152700StrataMR Valves and ShuntsMedtronic Neurosurgery K153041Bundled Neurological Shunts and Accessories Product Families Labeling Modification to Support MR Conditional LabelingIntegra LifeSciences Corporation K152897Integra DP Valve Systems (including Burr Hole Reservoirs and Stainless Steel Connectors), Gravity Compensating AccessoryIntegra LifeSciences Corporation

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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