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510(k) Data Aggregation
K Number
K242793Device Name
InsightersTM Single-use Bronchoscope/Insight Bimodel-Integral iS-B12A 4.6/2.0; InsightersTM Single-use Bronchoscope/Insight Bimodel-Integral iS-B22A 5.5 /2.6; InsightersTM Single-use Bronchoscope/Insight Bimodel-Integral iS-B26A 6.0/3.0; InsightersTM Insight Workstation iS-PF1.
Manufacturer
Shenzhen Insighters Medical Technology Co., Ltd.
Date Cleared
2025-05-28
(254 days)
Product Code
EOQ
Regulation Number
874.4680Why did this record match?
Applicant Name (Manufacturer) :
Shenzhen Insighters Medical Technology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Insighters(TM) Single-use Bronchoscope System provides images for the observation, diagnosis and treatment of trachea, bronchus and lung area.
It is indicated for diseases of the trachea and bronchi other than contraindications.
The Insighters(TM) Single-use Bronchoscope System is generally in-hospital use.
The Insighters(TM) Single-use Bronchoscope System is for use by trained clinicians/physicians only.
Device Description
The Single-use Flexible Video Bronchoscope (Insighters™ Single-use Bronchoscope System) consists of an Single-use Bronchoscope (iS-B12A/ iS-B22A/iS-B26A) and an Insight Workstation(iS-PF1) which is a compatible displaying unit.
The Single-use Bronchoscope consists of an insertion part (including the head end part, a bending part, and Main Hose part) and an operation part (including an electrical interface, a suction interface, a suction button, and clamp channel interface). It comes in 3 models: iS-B12A, iS-B22A, iS-B26A. The differences among the different models are only in size. This product is sterilized by ethylene oxide, single use, disposable, body orifices invasive and short-term use device.
The Insighters™ Insight Workstation (iS-PF1) consists of a display host and accessories: Power adaptor (model PH50-12), Connection Cable. The Insight workstation supports connection with Single-use bronchoscope by Connection Cable. It can supply power and processes the images for medical electronic endoscope. It is a reusable monitor and no contact with the patient.
The Insighters™ Single-use Bronchoscope System is to provide images for the observation, diagnosis and treatment of trachea, bronchus and lung area.
This product is a portable electronic endoscope. It has the characteristics of clear image, small size, light weight, easy to carry, flexible operation, easy to learn and use, etc.
This product contains a working channel, which is convenient for use after insertion of endoscopic accessories.
The applied part of this product is the insertion part of the Single-use Bronchoscope.
Single use application of this product minimises the risk of cross-contamination of the patient.
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K Number
K232529Device Name
Disposable Double Lumen Endobronchial Tube
Manufacturer
Shenzhen Insighters Medical Technology Co., Ltd.
Date Cleared
2024-05-13
(266 days)
Product Code
CBI
Regulation Number
868.5740Why did this record match?
Applicant Name (Manufacturer) :
Shenzhen Insighters Medical Technology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Disposable Double Lumen Endobronchial Tube is used to isolate the left or right lung of a patient for surgery, one lung ventilation or one lung anesthesia.
It is indicated for patients with pathological lung conditions or other medical conditions that require endobronchial intubation, mechanical ventilation and isolation of one lung from the other, e.g. for thoracic surgery.
The Disposable Double Lumen Endobronchial Tube is indicated for adults use only.
Device Description
The Disposable Double Lumen Endobronchial Tube is a sterile, single patient use PVC Double-Lumen Endobronchial Tube (also referred to as a DLT) that is inserted into the trachea via the mouth in order to selectively ventilate one lung.
The Disposable Double Lumen Endobronchial Tube is consisted with double lumen tube with the body including 2 cuffs (Bronchial Cuff and Tracheal Cuff).
The tracheal cuff provides sealing against tracheal wall and the corresponding pilot balloon indicates state of cuff inflation/deflation. Similarly, the bronchial cuff provides sealing against bronchial wall and the corresponding pilot balloon indicates state of cuff inflation/deflation. It is fitted with a stylet to enable shaping of the tube for navigation during intubation. When the suction is necessary, this device can be possible to be assemble with suction catheter which is 8Fr or 10Fr with PVC and this device is packaged with two suction catheters.
The Disposable Double Lumen Endobronchial Tube comes in three models, each model include two types: Ordinary Left Type, Ordinary Right Type, Visible Left Type B, Visible Right Type B, Visible Left Type, Visible Right Type. Each type will be available in six sizes: 28 Fr, 32 Fr, 35 Fr, 37 Fr, 39 Fr and 41 Fr.
The device is composed of biologically safe materials. It is indicated for patients with pathological lung conditions or other medical conditions that require endobronchial intubation, mechanical ventilation and isolation of one lung from the other, e.g. for thoracic surgery. The Disposable Double Lumen Endobronchial Tube is indicated for adults use only. Environments of use: Hospital-OR and ICU.
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K Number
K232580Device Name
Disposable Endobronchial Blocker Tube
Manufacturer
Shenzhen Insighters Medical Technology Co., Ltd.
Date Cleared
2023-12-14
(111 days)
Product Code
CBI
Regulation Number
868.5740Why did this record match?
Applicant Name (Manufacturer) :
Shenzhen Insighters Medical Technology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Disposable Endobronchial Blocker Tube is intended to differentially intubate a patient's bronchus in order to isolate the left or right lung for procedures that require one-lung ventilation. The 5Fr Endobronchial Blocked for infants populations; The 7Fr Endobronchial Blocker Tube is indicated for children populations; The 9Fr Endobronchial Blocker Tube is indicated for adults use only.
Patient Population: Patients requiring one lung isolation. Environment of Use: Hospitals-OR and ICU.
Device Description
The Disposable Endobronchial Blocker Tube is used to isolate the left or right lung of a patient for surgery, one lung ventilation or one lung anesthesia. It is composed of blocker catheter, cuff, three-way connector, tube connector, one-way valve (with a pilot balloon) and multifunctional adaptor.
The blocker catheter has a flexible angled tip which can be easily placed into desired bronchus. It also contains a polyurethane cuff at its distal tip to create an effective seal within the inner bronchial wall and minimize potential trauma to the bronchus. The proximal end of the blocker catheter is bonded with a one-way valve and a pilot balloon assembly. This pilot balloon assembly facilitates inflation of the distal balloon and maintains inflation until it is released. The distance markings on the blocker catheter indicate how far the blocker has been advanced.
The multi-functional adaptor can be used by connecting a blocker tube to various endotracheal tubes and anesthetic circuits.
The Disposable Endobronchial Blocker Tube is available in three models: 5Fr, 7Fr and 9Fr. The device is composed of biologically safe materials. It is supplied sterile and intended for single use only.
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