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FDA 510(k)

M. Blue Adjustable Shunt System

K-Number: K192266 · 2019-11-21

ApplicantAesculap, Inc.
Decision Date2019-11-21
Product CodeJXG
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

M. Blue Adjustable Shunt System is a medical device manufactured by Aesculap, Inc.. It received FDA 510(k) clearance on 2019-11-21 under approval number K192266. 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 M. Blue Adjustable Shunt System?

M. Blue Adjustable Shunt System is a medical device that received FDA 510(k) clearance on 2019-11-21. It is manufactured by Aesculap, Inc.. The 510(k) number is K192266.

When was M. Blue Adjustable Shunt System approved by the FDA?

M. Blue Adjustable Shunt System received FDA 510(k) clearance on 2019-11-21, under approval number K192266.

What company makes M. Blue Adjustable Shunt System?

M. Blue Adjustable Shunt System is manufactured by Aesculap, Inc..

What is the FDA product code for M. Blue Adjustable Shunt System?

The FDA product code for M. Blue Adjustable Shunt System is JXG.

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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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