FDA.reportPublic FDA data

510(k) K250243

Device
ProVu Single Use Video Stylet with Reinforced ET Tube (Size 6.5) (038-995-065U); ProVu Single Use Video Stylet with Reinforced ET Tube (Size 7.0) (038-995-070U); ProVu Single Use Video Stylet with Reinforced ET Tube (Size 7.5) (038-995-075U); ProVu Single Use Video Stylet with Reinforced ET Tube (Size 8.0) (038-995-080U)
Applicant
Flexicare Medical Limited.
510(k) number
K250243
Product code
BTR
Decision
Substantially Equivalent (SESE)
Decision date
2025-05-20
Date received
2025-01-27
Regulation
868.5730
Classification name
Tube, Tracheal (W/Wo Connector)
Medical specialty
Anesthesiology
Review panel
Anesthesiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
Rebecca Funston
Address
Cynon Valley Business Park Mountain Ash Rhondda Cynon Taf GB CF45 4ER CF45 4ER

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code BTR#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K250173Shiley™ Oral RAE Tracheal Tube Cuffless, Murphy Eye (113-XX) Shiley™ Nasal RAE Tracheal Tube Cuffless, Murphy Eye (114-XX) Shiley™ Oral RAE Tracheal Tube Cuffed, Murphy Eye (115-XX) Shiley™ Oral RAE Tracheal Tube with TaperGuard™ Cuff, Murphy Eye (115-XXOR) Shiley™ Nasal RAE Tracheal Tube with TaperGuard™ Cuff, Murphy Eye (119-XXNR)Covidien, LLC2025-10-06
K243785Shiley™ Oral/Nasal Tracheal Tube with TaperGuard™ Cuff Reinforced, Murphy Eye Shiley™ Tracheal Tube TaperGuard™ Cuff Reinforced with Stylet Shiley™ Lo-Contour Oral/Nasal Tracheal Tube Cuffed Reinforced Shiley™ Lo-Contour Oral/Nasal Tracheal Tube Cuffed Reinforced, Murphy Eye Shiley™ Oral/Nasal Tracheal Tube Cuffless ReinforcedCovidien, LLC2025-09-25
K243579AeroJet Ventilation CatheterPipeline Medical Products, LLC2025-08-13
K251499Frova Intubating Introducer (C-CAE-14.0-70-FII); Frova Intubating Introducer (C-CAE-14.0-70-FI); Frova Intubating Introducer (C-CAE-14.0-70-FIC); Frova Intubating Introducer (C-CAE-14.0-70-FIC-SPOPS)William Cook Europe Aps2025-06-11
K242495LMA Fastrach ETT SUTeleflex Medical2025-04-29
K241451Rusch Endotracheal Tubes (Reinforced); Rusch Endotracheal Tubes (Safety Clear); Rusch Endotracheal Tubes (Safety Clear Pediatric)Teleflex Incorporated2025-02-11
K233341Shiley™ Oral/Nasal Endotracheal Tube Intermediate Cuff, Non-DEHP (87430, 87435, 87440, 87445, 87450, 87455, 87460, 87465, 87470, 87475, 87480, 87485, 87490, 87495, 87410)Covidien, LLC2024-05-20
K223130Shiley™ Pediatric Oral/Nasal Endotracheal Tube with TaperGuard™ Cuff, Non DEHP (86125, 86130, 86135, 86140, 86145, 86150, 86155, 86160)Covidien2023-08-30
K211543Wei Nasal Jet TubeWell Lead Medical Co., Ltd.2022-07-21
K213028Tenax Laser Resistant Endotracheal TubeBryan Medical, Inc.2021-10-21
K200761Tenax Laser Resistant Endotracheal TubeBryan Medical, Inc.2020-11-25
K192120Venner PneuX™ ETT (Endotracheal Tube) 6 mm, Venner PneuX™ ETT (Endotracheal Tube) 7 mm, Venner PneuX™ ETT (Endotracheal Tube) 8 mm, Venner PneuX™ ETT (Endotracheal Tube) 9 mmVenner Medical (Singapore) Pte, Ltd.2020-02-14
K190878Trach- Vac Endotracheal Tube (SFTVPU) Subglottic Suction Tube with Salter Flex-Tip and Salter ThinCuff, Trach- Vac Endotracheal Tube (SFTVVC) Subglottic Suction Tube with Salter Flex-Tip and Salter ThinCuffSalter Labs, Inc.2020-01-10
K182739Endotracheal Tube with Evacuation LumenWell Lead Medical Co., Ltd.2019-12-11
K192324Sheridan Spiral-Flex Endotracheal TubesTeleflexmedical, Inc.2019-12-06