<?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>ca57de81-95f9-47f2-8f2f-bbf465a19d85</publicDeviceRecordKey><publicVersionStatus>Update</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>4</publicVersionNumber><publicVersionDate>2023-11-17</publicVersionDate><devicePublishDate>2016-09-16</devicePublishDate><deviceCommDistributionEndDate xsi:nil="true"/><deviceCommDistributionStatus>In Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>B3961501580</deviceId><deviceIdType>Primary</deviceIdType><deviceIdIssuingAgency>HIBCC</deviceIdIssuingAgency><containsDINumber xsi:nil="true"/><pkgQuantity xsi:nil="true"/><pkgDiscontinueDate xsi:nil="true"/><pkgStatus xsi:nil="true"/><pkgType xsi:nil="true"/></identifier></identifiers><brandName>ESI</brandName><versionModelNumber>15-0158</versionModelNumber><catalogNumber xsi:nil="true"/><dunsNumber>002212793</dunsNumber><companyName>FTT MEDICAL, INC.</companyName><deviceCount>1</deviceCount><deviceDescription>REPLACEMENT DILATING  WINDOW FOR YEOMAN SIGMOIDOSCOPE OR ULTRASOUND PROCTOSCOPE</deviceDescription><DMExempt>false</DMExempt><premarketExempt>true</premarketExempt><deviceHCTP>false</deviceHCTP><deviceKit>false</deviceKit><deviceCombinationProduct>false</deviceCombinationProduct><singleUse>false</singleUse><lotBatch>true</lotBatch><serialNumber>false</serialNumber><manufacturingDate>true</manufacturingDate><expirationDate>false</expirationDate><donationIdNumber>false</donationIdNumber><labeledContainsNRL>false</labeledContainsNRL><labeledNoNRL>false</labeledNoNRL><MRISafetyStatus>Labeling does not contain MRI Safety Information</MRISafetyStatus><rx>false</rx><otc>false</otc><contacts/><gmdnTerms><gmdn><gmdnCode>15058</gmdnCode><gmdnPTName>Rigid optical sigmoidoscope, reusable</gmdnPTName><gmdnPTDefinition>An endoscope with a rigid inserted portion intended for the visual examination and treatment of the sigmoid colon (the distal S-shaped part of the large intestine leading to the rectum). It is inserted through the anus during sigmoidoscopy or proctosigmoidoscopy. The anatomical images are illuminated by a built-in or external light source and can be viewed by the user through relayed lens optics or a fibreoptic bundle. This device is typically used to examine the structures and lining of the sigmoid colon and for indications of altered bowel habit, colonic cancer, or polyps. This is a reusable device.</gmdnPTDefinition><implantable>false</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn></gmdnTerms><productCodes><fdaProductCode><productCode>GCF</productCode><productCodeName>Proctoscope</productCodeName></fdaProductCode></productCodes><deviceSizes/><environmentalConditions/><sterilization><deviceSterile>false</deviceSterile><sterilizationPriorToUse>true</sterilizationPriorToUse><methodTypes><sterilizationMethod>Moist Heat or Steam Sterilization</sterilizationMethod></methodTypes></sterilization></device>