FDA.reportPublic FDA data

510(k) K201026

Device
sOLVe Tube
Applicant
Hytek Medical, Inc.
510(k) number
K201026
Product code
CBI
Decision
Substantially Equivalent (SESE)
Decision date
2021-08-10
Date received
2020-04-20
Regulation
868.5740
Classification name
Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)
Medical specialty
Anesthesiology
Review panel
Anesthesiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Nir Hoftman
Address
8741 Shirley Ave. Northridge CA US 91324 91324

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code CBI#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K251950Endobronchial Blocker Tube (EBT0109); Endobronchial Blocker Tube (EBT0107); Endobronchial Blocker Tube (EBT0105); Endobronchial Blocker Tube (EBT0109S); Endobronchial Blocker Tube (EBT0107S); Endobronchial Blocker Tube (EBT0105S); Endobronchial Blocker Tube (EBT0209); Endobronchial Blocker Tube (EBT0207); Endobronchial Blocker Tube (EBT0205); Endobronchial Blocker Tube (EBT0209S); Endobronchial Blocker Tube (EBT0207S); Endobronchial Blocker Tube (EBT0205S)Hangzhou Tappa Medical Technology Co., Ltd.2026-03-20
K253096Chartis Precision CatheterPulmonx Corporation2026-02-13
K232529Disposable Double Lumen Endobronchial TubeShenzhen Insighters Medical Technology Co., Ltd.2024-05-13
K232580Disposable Endobronchial Blocker TubeShenzhen Insighters Medical Technology Co., Ltd.2023-12-14
K222340Chartis Precision CatheterPulmonx Corporation2022-12-01
K203749Ambu VivaSight 2 DLT, Ambu VivaSight 2 Adapter CableAmbu A/S2021-05-03
K200968ABC33L, ABC35L, ABC37L, ABC39L, ABC33R, ABC35R, ABC37R, ABC39RInsung Medical Co., Ltd.2020-12-28
K181886VivaSight-DL SystemEtview , Ltd.2018-11-14
K180253Sheridan Endobronchial TubesTeleflex Medical2018-11-02
K1605425.0 Fr Arndt Endobronchial Blocker SetCook Incorporated2016-08-02
K152251Endobronchial TubeHenan Tuoren Medical Device Co., Ltd.2016-06-10
K141888RUSCH ENDOBRONCHIAL TUBESTeleflexmedical, Inc.2015-04-15
K123853VIVASIGHT-DL SYSTEMEtview , Ltd.2013-04-15
K121462EZ-BLOCKEREz-Blocker B.V.2012-09-28
K120334VIVA EBEtview , Ltd.2012-06-08