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)

CODMAN CERTAS PROGRAMMABLE VALVE SYSTEM

K-Number: K113526 · 2012-02-16

ApplicantMedos International SARL
Decision Date2012-02-16
Product CodeJXG
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

CODMAN CERTAS PROGRAMMABLE VALVE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Medos International SARL. It received FDA 510(k) clearance on 2012-02-16 under 510(k) number K113526. 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 CODMAN CERTAS PROGRAMMABLE VALVE SYSTEM?

CODMAN CERTAS PROGRAMMABLE VALVE SYSTEM is a medical device that received FDA 510(k) clearance on 2012-02-16. The listed applicant is Medos International SARL. The 510(k) number is K113526.

When did CODMAN CERTAS PROGRAMMABLE VALVE SYSTEM receive FDA 510(k) clearance?

CODMAN CERTAS PROGRAMMABLE VALVE SYSTEM received FDA 510(k) clearance on 2012-02-16, under 510(k) number K113526.

Who is the listed applicant for CODMAN CERTAS PROGRAMMABLE VALVE SYSTEM?

The FDA 510(k) record lists Medos International SARL as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CODMAN CERTAS PROGRAMMABLE VALVE SYSTEM?

The FDA product code for CODMAN CERTAS PROGRAMMABLE VALVE SYSTEM 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

Other records listing Medos International SARL as applicant

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.

K254157CROSSNAV Navigation Enabled Instruments for Disc Preparation and InterbodyK260240SYMPHONY Navigation Ready InstrumentsK253249TriALTIS™ Spine SystemK243249TriALTIS™ Spine SystemK241893CROSSNAV Navigation Enabled Instruments and UNAS Navigation ArraysK242042TriALTIS™ Spine System

View all 90 devices →

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.

↑