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FDA 510(k)

EKOS ultrasound EVD Device, EVD Control Unit

K-Number: K172035 · 2018-03-24

ApplicantBtg International, Inc.
Decision Date2018-03-24
Product CodeJXG
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

EKOS ultrasound EVD Device, EVD Control Unit is a medical device manufactured by Btg International, Inc.. It received FDA 510(k) clearance on 2018-03-24 under approval number K172035. 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 EKOS ultrasound EVD Device, EVD Control Unit?

EKOS ultrasound EVD Device, EVD Control Unit is a medical device that received FDA 510(k) clearance on 2018-03-24. It is manufactured by Btg International, Inc.. The 510(k) number is K172035.

When was EKOS ultrasound EVD Device, EVD Control Unit approved by the FDA?

EKOS ultrasound EVD Device, EVD Control Unit received FDA 510(k) clearance on 2018-03-24, under approval number K172035.

What company makes EKOS ultrasound EVD Device, EVD Control Unit?

EKOS ultrasound EVD Device, EVD Control Unit is manufactured by Btg International, Inc..

What is the FDA product code for EKOS ultrasound EVD Device, EVD Control Unit?

The FDA product code for EKOS ultrasound EVD Device, EVD Control Unit is JXG.

Related Clinical Trials

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Related PubMed Literature

PMID: 42105288 Evaluating regulatory oversight through major Expert review of medical devices (2026) PMID: 41938602 AI-enabled cardiovascular devices: a lifecycle playbook for evidence, change control, and post-market assurance. Frontiers in digital health (2026) PMID: 41516911 Substance-Based Medical Device in Wound Care: Bridging Regulatory Clarity and Therapeutic Innovation. Polymers (2025) PMID: 40624055 Establishment of a clinical workflow for in vivo Raman spectroscopy during head and neck cancer surgery. Scientific reports (2025)

Other Devices by Btg International, Inc.

K162771EkoSonic Endovascular System with Control Unit 4.0 K182324EkoSonic Endovascular System K191119EkoSonic Endovascular Device K183361EkoSonic Endovascular Device with Control Unit 4.0

Related Devices (Code: JXG)

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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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