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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 the device name listed in this FDA 510(k) record. The listed applicant is Aesculap, Inc.. It received FDA 510(k) clearance on 2019-11-21 under 510(k) 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. The listed applicant is Aesculap, Inc.. The 510(k) number is K192266.

When did M. Blue Adjustable Shunt System receive FDA 510(k) clearance?

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

Who is the listed applicant for M. Blue Adjustable Shunt System?

The FDA 510(k) record lists Aesculap, Inc. as the applicant. This does not by itself establish the device manufacturer.

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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Related Devices (Code: 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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