FDA 510(k)

Codman EDS3 CSF External Drainage System

K-Number: K162437 · 2016-10-28

Decision Date2016-10-28

Product CodeJXG

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

Codman EDS3 CSF External Drainage System is a medical device manufactured by Codman & Shurtleff, Inc.. It received FDA 510(k) clearance on 2016-10-28 under approval number K162437. 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 EDS3 CSF External Drainage System?

Codman EDS3 CSF External Drainage System is a medical device that received FDA 510(k) clearance on 2016-10-28. It is manufactured by Codman & Shurtleff, Inc.. The 510(k) number is K162437.

When was Codman EDS3 CSF External Drainage System approved by the FDA?

Codman EDS3 CSF External Drainage System received FDA 510(k) clearance on 2016-10-28, under approval number K162437.

What company makes Codman EDS3 CSF External Drainage System?

Codman EDS3 CSF External Drainage System is manufactured by Codman & Shurtleff, Inc..

What is the FDA product code for Codman EDS3 CSF External Drainage System?

The FDA product code for Codman EDS3 CSF External Drainage System is JXG.

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Other Devices by Codman & Shurtleff, Inc.

K153347Codman Microsensor Basic Kit, Codman Microsensor Plastic Skull Bolt Kit, Codman Microsensor Ventricular Catheter Kit with Tuohy-Borst Adapter,Codman Microsensor Metal Skull Bolt Kit, Codman Microsensor Ventricular Catheter Kit K173192CereLink ICP Sensor Basic Kit, CereLink ICP Sensor Metal Skull Bolt Kit, CereLink ICP Sensor Plastic Skull Bolt Kit, CereLink ICP Sensor Ventricular Catheter Kit K172537Codman EDS 3 CSF External Drainage System, Codman EDS 3 CSF External Drainage System Collection Bag K172022CODMAN Hydrocephalus Valves, Catheters & Accessories (Bundled) K171862GALAXY G3 Mini Microcoil Delivery System K171747MICRUSFRAME 10 Stretch Resistant Microcoil Delivery System, MICRUSFRAME 18 Stretch Resistant Microcoil Delivery System, DELTAFILL 18 Stretch Resistant Microcoil Delivery System, DELTAXSFT 10 Stretch Resistant Microcoil Delivery System, GALAXY G3 FILL and GALAXY G3 XSFT Stretch Resistant Microcoil Delivery System

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Related Devices (Code: JXG)

K161605Smart External Drain (SED) SystemAqueduct Critical Care, Inc. K161992Horizontal-Vertical Lumbar Valve Systems, Spetzler Lumbar Peritoneal Shunt SystemsIntegra LifeSciences Corporation K152700StrataMR Valves and ShuntsMedtronic Neurosurgery K153041Bundled Neurological Shunts and Accessories Product Families Labeling Modification to Support MR Conditional LabelingIntegra LifeSciences Corporation K152897Integra DP Valve Systems (including Burr Hole Reservoirs and Stainless Steel Connectors), Gravity Compensating AccessoryIntegra LifeSciences Corporation K172759Smart External Drain (SED) SystemAqueduct Critical Care, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.