FDA 510(k)

Esophageal TTS Stent

K-Number: K211706 · 2021-10-08

Decision Date2021-10-08

Product CodeESW

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

Esophageal TTS Stent is a medical device manufactured by Taewoong Medical Co., Ltd.. It received FDA 510(k) clearance on 2021-10-08 under approval number K211706. 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 TTS Stent?

Esophageal TTS Stent is a medical device that received FDA 510(k) clearance on 2021-10-08. It is manufactured by Taewoong Medical Co., Ltd.. The 510(k) number is K211706.

When was Esophageal TTS Stent approved by the FDA?

Esophageal TTS Stent received FDA 510(k) clearance on 2021-10-08, under approval number K211706.

What company makes Esophageal TTS Stent?

Esophageal TTS Stent is manufactured by Taewoong Medical Co., Ltd..

What is the FDA product code for Esophageal TTS Stent?

The FDA product code for Esophageal TTS Stent is ESW.

Other Devices by Taewoong Medical Co., Ltd.

K221482Esophageal TTS Stent K221071Niti-S Biliary Slim M Stent K223067Niti-S Duodenal Stent; Niti-S Colonic Comfort Stent K223626Niti-S Biliary Speed D Stent K223256Optimos Cystotome K251123Niti-S Biliary Stent; Niti-S Biliary Slim M Stent

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Related Devices (Code: ESW)

K162717Evolution Esophageal Stent System Partially CoveredCook Ireland, Ltd. K180144Agile Esophageal Stent SystemBoston Scientific Corporation K172813Esophageal Stent SystemMicro-Tech (Nanjing) Co., Ltd. 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

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.