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FDA 510(k)

MAURICE WORLDWIDE SHUNT SYSTEM

K-Number: K973525 · 1997-12-16

ApplicantIntegra Neurocare, LLC
Decision Date1997-12-16
Product CodeJXG
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

MAURICE WORLDWIDE SHUNT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Integra Neurocare, LLC. It received FDA 510(k) clearance on 1997-12-16 under 510(k) number K973525. 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 MAURICE WORLDWIDE SHUNT SYSTEM?

MAURICE WORLDWIDE SHUNT SYSTEM is a medical device that received FDA 510(k) clearance on 1997-12-16. The listed applicant is Integra Neurocare, LLC. The 510(k) number is K973525.

When did MAURICE WORLDWIDE SHUNT SYSTEM receive FDA 510(k) clearance?

MAURICE WORLDWIDE SHUNT SYSTEM received FDA 510(k) clearance on 1997-12-16, under 510(k) number K973525.

Who is the listed applicant for MAURICE WORLDWIDE SHUNT SYSTEM?

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

What is the FDA product code for MAURICE WORLDWIDE SHUNT SYSTEM?

The FDA product code for MAURICE WORLDWIDE SHUNT SYSTEM is JXG.

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Other records listing Integra Neurocare, LLC as applicant

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Related Devices (Code: JXG)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261004Codman® Distal Peritoneal Catheter, Barium Open End (82-1682); Codman® HOLTER® Peritoneal Catheter (SALMON Design) (82-1684)Integra Lifesciences Production CorporationK251598IntellidropBrainspace, Inc.K250636Sophy Mini Monopressure Valve (SM1)SophysaK252514EVAC-MRIPhasor Health, LLCK243531Codman Libertís Shunt Catheter with Bactiseal and Endexo TechnologyIntegra Lifesciences Production CorporationK243552Codman Libertís™ 1.5 mm EVD Catheter with Bactiseal® and Endexo® Technology with Luer Connection (821761); Codman Libertís™ 1.9 mm EVD Catheter with Bactiseal® and Endexo® Technology with Luer Connection (821762)Integra Lifesciences Production 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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