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FDA 510(k)

Codman EDS 3 CSF External Drainage System, Codman EDS 3 CSF External Drainage System Collection Bag

K-Number: K172537 · 2017-10-16

ApplicantCodman & Shurtleff, Inc.
Decision Date2017-10-16
Product CodeJXG
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Codman EDS 3 CSF External Drainage System, Codman EDS 3 CSF External Drainage System Collection Bag is a medical device manufactured by Codman & Shurtleff, Inc.. It received FDA 510(k) clearance on 2017-10-16 under approval number K172537. 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 EDS 3 CSF External Drainage System, Codman EDS 3 CSF External Drainage System Collection Bag?

Codman EDS 3 CSF External Drainage System, Codman EDS 3 CSF External Drainage System Collection Bag is a medical device that received FDA 510(k) clearance on 2017-10-16. It is manufactured by Codman & Shurtleff, Inc.. The 510(k) number is K172537.

When was Codman EDS 3 CSF External Drainage System, Codman EDS 3 CSF External Drainage System Collection Bag approved by the FDA?

Codman EDS 3 CSF External Drainage System, Codman EDS 3 CSF External Drainage System Collection Bag received FDA 510(k) clearance on 2017-10-16, under approval number K172537.

What company makes Codman EDS 3 CSF External Drainage System, Codman EDS 3 CSF External Drainage System Collection Bag?

Codman EDS 3 CSF External Drainage System, Codman EDS 3 CSF External Drainage System Collection Bag is manufactured by Codman & Shurtleff, Inc..

What is the FDA product code for Codman EDS 3 CSF External Drainage System, Codman EDS 3 CSF External Drainage System Collection Bag?

The FDA product code for Codman EDS 3 CSF External Drainage System, Codman EDS 3 CSF External Drainage System Collection Bag is JXG.

Related Clinical Trials

NCT07475091 Standardizing Swallow Pressure Measurements NOT_YET_RECRUITING NCT01174108 Allogeneic Hematopoietic Stem Cell Transplantation for Severe Aplastic Anemia and Other Bone Marrow Failure Syndromes Using G-CSF Mobilized CD34+ Selected Hematopoietic Precursor Cells Co-Infused With a Reduced Dose of Non-Mobilized Donor T-cells RECRUITING NCT06642935 A Study to Explore Improved Features and a Simplified Treatment Approach for a Totally Implantable Cochlear Implant (TICI) Research System in Adults With Severe Hearing Loss ACTIVE_NOT_RECRUITING NCT06385392 Continuous Wearable Monitor for the Detection and Release of Freezing of Gait. COMPLETED NCT06253858 Ultrasound (US) Guided External Ventricular Catheter Placement RECRUITING NCT07287124 A Pivotal Study to Evaluate the Clinical Benefit, Performance and Safety of a Totally Implantable Cochlear Implant (TICI) System in Adults RECRUITING

Related PubMed Literature

PMID: 37288633 [Roadmap of Medical Device for Implanted Brain-computer Interface]. Zhongguo yi liao qi xie za zhi = Chinese journal of medical instrumentation (2023)

Other Devices by Codman & Shurtleff, Inc.

K162437Codman EDS3 CSF External Drainage System 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 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

View all 11 devices →

Related Devices (Code: JXG)

K162437Codman EDS3 CSF External Drainage SystemCodman & Shurtleff, Inc. 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

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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