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 the device name listed in this FDA 510(k) record. The listed applicant is Integra LifeSciences Corporation. It received FDA 510(k) clearance on 2019-10-11 under 510(k) 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. The listed applicant is Integra LifeSciences Corporation. The 510(k) number is K191684.

When did MoniTorr ICP External Drainage and Monitoring System, LimiTorr Volume Limiting External CSF Drainage System receive FDA 510(k) clearance?

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

Who is the listed applicant for MoniTorr ICP External Drainage and Monitoring System, LimiTorr Volume Limiting External CSF Drainage System?

The FDA 510(k) record lists Integra LifeSciences Corporation as the applicant. This does not by itself establish the device manufacturer.

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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Official Source

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