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FDA 510(k)

Esophageal Stent System

K-Number: K172813 · 2018-05-18

ApplicantMicro-Tech (Nanjing) Co., Ltd.
Decision Date2018-05-18
Product CodeESW
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Esophageal Stent System is a medical device manufactured by Micro-Tech (Nanjing) Co., Ltd.. It received FDA 510(k) clearance on 2018-05-18 under approval number K172813. The device is classified under product code ESW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Esophageal Stent System?

Esophageal Stent System is a medical device that received FDA 510(k) clearance on 2018-05-18. It is manufactured by Micro-Tech (Nanjing) Co., Ltd.. The 510(k) number is K172813.

When was Esophageal Stent System approved by the FDA?

Esophageal Stent System received FDA 510(k) clearance on 2018-05-18, under approval number K172813.

What company makes Esophageal Stent System?

Esophageal Stent System is manufactured by Micro-Tech (Nanjing) Co., Ltd..

What is the FDA product code for Esophageal Stent System?

The FDA product code for Esophageal Stent System is ESW.

Related Clinical Trials

NCT03736226 A Post-Approval, Single-Arm Study of the SYNERGY Stent System in China ACTIVE_NOT_RECRUITING NCT07611968 Prospective Evaluation of Physician Modified Endografts for Aortic Disease NOT_YET_RECRUITING NCT05864560 Ankura™ AAA, Cuff and AUI Stent Graft System Post-Market Clinical Follow-Up ACTIVE_NOT_RECRUITING NCT05639569 Ankura™ TAA Stent Graft System Post-Market Clinical Follow-up Study ACTIVE_NOT_RECRUITING NCT06710938 Thoracoabdominal Artery Stent Graft System Exploratory Study RECRUITING NCT06249776 Gravity Stent-Retriever System For Reperfusion Of Large Vessel Occlusion Stroke Trial COMPLETED

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Related Devices (Code: ESW)

K162717Evolution Esophageal Stent System – Partially CoveredCook Ireland, Ltd. K180144Agile Esophageal Stent SystemBoston Scientific Corporation K182910Segmented Esophageal Stent SystemMicro-Tech (Nanjing) Co., Ltd. K200860HANAROSTENT Esophagus TTS (CCC), HANAROSTENT Esophagus TTS (NCN)M.I.Tech Co., Ltd. K211960Agile Esophageal OTW Stent SystemBoston Scientific Corporation K213251HANAROSTENT Esophagus Asymmetric (CCC)M.I.Tech Co., Ltd.

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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