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FDA 510(k)

External Drainage System

K-Number: K221694 · 2023-02-09

ApplicantJmed(Shenzhen) Technology Limited
Decision Date2023-02-09
Product CodeJXG
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

External Drainage System is a medical device manufactured by Jmed(Shenzhen) Technology Limited. It received FDA 510(k) clearance on 2023-02-09 under approval number K221694. 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 External Drainage System?

External Drainage System is a medical device that received FDA 510(k) clearance on 2023-02-09. It is manufactured by Jmed(Shenzhen) Technology Limited. The 510(k) number is K221694.

When was External Drainage System approved by the FDA?

External Drainage System received FDA 510(k) clearance on 2023-02-09, under approval number K221694.

What company makes External Drainage System?

External Drainage System is manufactured by Jmed(Shenzhen) Technology Limited.

What is the FDA product code for External Drainage System?

The FDA product code for External Drainage System is JXG.

Related Clinical Trials

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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)

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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