FDA 510(k)

Esophageal Stent System

K-Number: K172813 · 2018-05-18

Decision Date2018-05-18

Product CodeESW

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

Esophageal Stent System is the device name listed in this FDA 510(k) record. The listed applicant is Micro-Tech (Nanjing) Co., Ltd.. It received FDA 510(k) clearance on 2018-05-18 under 510(k) 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. The listed applicant is Micro-Tech (Nanjing) Co., Ltd.. The 510(k) number is K172813.

When did Esophageal Stent System receive FDA 510(k) clearance?

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

Who is the listed applicant for Esophageal Stent System?

The FDA 510(k) record lists Micro-Tech (Nanjing) Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Esophageal Stent System?

The FDA product code for Esophageal Stent System is ESW.

Other records listing Micro-Tech (Nanjing) Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252492Visualized Access and Delivery Catheter; PB Digital Controller K251692Advanced Tissue Resection Device K250229Dual Action Tissue Closure Device K243388Disposable Distal Cap K243471Extraction Basket K230127Biliary Plastic Stent, Biliary Plastic Stent Introducer, Biliary Plastic Stent Set, Biliary Plastic Stent Introducer/ short-wire compatible, Biliary Plastic Stent Set/ short-wire compatible

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Related Devices (Code: ESW)

K261978WallFlex Esophageal Stent System;Agile Esophageal Over-the-Wire (OTW) Stent SystemBoston Scientific Corporation K253327HANAROSTENT Esophagus Upper (CCC)M.I.Tech Co., Ltd.K243619Niti-S Esophageal Stent; Esophageal TTS StentTaewoong Medical Co., Ltd.K251265Resilience Fully Covered Esophageal Stent SystemMerit Medical Systems, Inc.K233939Ultraflex Esophageal NG Stent System; WallFlex Esophageal Stent SystemBoston Scientific K233837Agile Esophageal Stent SystemBoston Scientific 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.