Expedited Review Granted? No. Combination Product, No. Approval Order Statement Approval for the karl storz semi-rigid ttts fetoscopy instrument set, the karl ...QuickLinks:SkiptomainpagecontentSkiptoSearchSkiptoTopicsMenuSkiptoCommonLinksU.S.Food&DrugAdministration FollowFDAEnEspañolSearchFDA HomeFoodDrugsMedicalDevicesRadiation-EmittingProductsVaccines,Blood&BiologicsAnimal&VeterinaryCosmeticsTobaccoProducts HumanitarianDeviceExemption(HDE)FDAHomeMedicalDevicesDatabases-510(k)|DeNovo|Registration&Listing|AdverseEvents|Recalls|PMA|HDE|Classification|StandardsCFRTitle21|Radiation-EmittingProducts|X-RayAssembler|MedsunReports|CLIA|TPLC NewSearchBacktoSearchResultsNote:thismedicaldevicehassupplements.Thedevicedescriptionmayhavechanged.Besuretolookatthesupplementstogetanup-to-dateviewofthisdevice. TradeNameFETOSCOPYINSTRUMENTSETClassificationNameamnioscope,transabdominal(fetoscope)(andaccessories)GenericNameamnioscope,transabdominal(fetoscope)(andaccessories)RegulationNumber884.1600ApplicantKARLSTORZENDOSCOPY-AMERICA,INC.2151e.grandave.elsegundo, CA 90245HDENumberH040005DateReceived06/30/2004DecisionDate03/31/2006ProductCodeHFA[RegisteredEstablishmentswithHFA]DocketNumber06M0163NoticeDate04/21/2006AdvisoryCommitteeObstetrics/GynecologySupplementTypehdeoriginalExpeditedReviewGranted?NoCombinationProductNoApprovalOrderStatement Approvalforthekarlstorzsemi-rigidtttsfetoscopyinstrumentset,thekarlstorzrigidtttsfetoscopyinstrumentsetwith0or12degreescope,andthekarlstorzrigidtttsfetoscopylnstrumentsetwith30degreescope.Thesedevicesareindicatedforselectivelaserphotocoagulation(slpc)inthetreatmentoftwin-to-twintransfusionsyndrome(ttts)forfetuseswhosegestationalageisbetween16and26weeks.ApprovalOrderApprovalOrderSummarySummaryofSafetyandProbableBenefitLabelingLabelingSupplements:S002 S006 --Linksonthispage:PageLastUpdated:08/23/2021Note:Ifyouneedhelpaccessinginformationindifferentfileformats,seeInstructionsforDownloadingViewersandPlayers.LanguageAssistanceAvailable:Español|繁體中文|Tiế