Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

SHUNTCHECK

K-Number: K123554 · 2013-03-07

ApplicantNeurodx Development, LLC
Decision Date2013-03-07
Product CodeJXG
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

SHUNTCHECK is the device name listed in this FDA 510(k) record. The listed applicant is Neurodx Development, LLC. It received FDA 510(k) clearance on 2013-03-07 under 510(k) number K123554. 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 SHUNTCHECK?

SHUNTCHECK is a medical device that received FDA 510(k) clearance on 2013-03-07. The listed applicant is Neurodx Development, LLC. The 510(k) number is K123554.

When did SHUNTCHECK receive FDA 510(k) clearance?

SHUNTCHECK received FDA 510(k) clearance on 2013-03-07, under 510(k) number K123554.

Who is the listed applicant for SHUNTCHECK?

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

What is the FDA product code for SHUNTCHECK?

The FDA product code for SHUNTCHECK is JXG.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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.

↑