<?xml version='1.0' encoding='UTF-8'?><device xmlns='http://www.fda.gov/cdrh/gudid' xmlns:xsi='http://www.w3.org/2001/XMLSchema-instance'><publicDeviceRecordKey>88ea42c3-231b-4fbd-84a7-1f7b9901ecd5</publicDeviceRecordKey><publicVersionStatus>Update</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>3</publicVersionNumber><publicVersionDate>2026-04-08</publicVersionDate><devicePublishDate>2021-10-15</devicePublishDate><deviceCommDistributionEndDate xsi:nil="true"/><deviceCommDistributionStatus>In Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>08809744973166</deviceId><deviceIdType>Primary</deviceIdType><deviceIdIssuingAgency>GS1</deviceIdIssuingAgency><containsDINumber xsi:nil="true"/><pkgQuantity xsi:nil="true"/><pkgDiscontinueDate xsi:nil="true"/><pkgStatus xsi:nil="true"/><pkgType xsi:nil="true"/></identifier></identifiers><brandName>Esophageal TTS Stent</brandName><versionModelNumber>EST1808F-22</versionModelNumber><catalogNumber xsi:nil="true"/><dunsNumber>689484322</dunsNumber><companyName>TAEWOONGMEDICAL.CO.,LTD</companyName><deviceCount>1</deviceCount><deviceDescription>Fully Covered Esophageal Stent System</deviceDescription><DMExempt>false</DMExempt><premarketExempt>false</premarketExempt><deviceHCTP>false</deviceHCTP><deviceKit>false</deviceKit><deviceCombinationProduct>false</deviceCombinationProduct><singleUse>true</singleUse><lotBatch>false</lotBatch><serialNumber>true</serialNumber><manufacturingDate>true</manufacturingDate><expirationDate>true</expirationDate><donationIdNumber>false</donationIdNumber><labeledContainsNRL>false</labeledContainsNRL><labeledNoNRL>false</labeledNoNRL><MRISafetyStatus>MR Conditional</MRISafetyStatus><rx>true</rx><otc>false</otc><contacts><customerContact><phone>323-692-0028</phone><phoneExtension xsi:nil="true"/><email>minsoo@taewoongusa.com</email></customerContact><customerContact><phone>+82319960641</phone><phoneExtension xsi:nil="true"/><email>contact@stent.net</email></customerContact></contacts><premarketSubmissions><premarketSubmission><submissionNumber>K211706</submissionNumber><supplementNumber>000</supplementNumber></premarketSubmission></premarketSubmissions><gmdnTerms><gmdn><gmdnCode>61751</gmdnCode><gmdnPTName>Polymer-metal oesophageal stent</gmdnPTName><gmdnPTDefinition>A non-bioabsorbable, expandable, tubular device intended to be implanted into the oesophagus to maintain luminal patency in strictures, prevent tumour in-growth, seal oesophageal fistulas, reduce acute bleeding from oesophageal varices, and/or to treat other lesions causing oesophageal leakage (e.g., anastomotic). It consists of a mesh structure made of metal which is covered/lined with a synthetic polymer material (e.g., silicone) that prevents lateral flow and tissue ingrowth and facilitates removability. It is typically expanded in situ (e.g., self-expands) and disposable devices intended to assist implantation may be included.</gmdnPTDefinition><implantable>true</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn></gmdnTerms><productCodes><fdaProductCode><productCode>ESW</productCode><productCodeName>Prosthesis, Esophageal</productCodeName></fdaProductCode></productCodes><deviceSizes><deviceSize><sizeType>Stent Diameter</sizeType><size unit="Millimeter" value="18"/><sizeText xsi:nil="true"/></deviceSize><deviceSize><sizeType>Stent Length</sizeType><size unit="Centimeter" value="8"/><sizeText xsi:nil="true"/></deviceSize><deviceSize><sizeType>Catheter Working Length</sizeType><size unit="Centimeter" value="220"/><sizeText xsi:nil="true"/></deviceSize></deviceSizes><environmentalConditions/><sterilization><deviceSterile>true</deviceSterile><sterilizationPriorToUse>false</sterilizationPriorToUse><methodTypes/></sterilization></device>