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Found 16 results
510(k) Data Aggregation
K Number
K191602Device Name
APA Oxy Blade
Manufacturer
Venner Medical (Singapore) Pte Ltd
Date Cleared
2019-08-02
(46 days)
Product Code
CCW
Regulation Number
868.5540Why did this record match?
Product Code :
CCW
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The APA Oxy Blade™ is a multi-functional, single-use, disposable larynoscope blade intended to assist in direct and indirect laryngoscopy and to facilitate and aid in tracheal intubation in routine and difficult airways in adult patients. The APA Oxy Blade™ incorporates an oxygen tube adaptor and tubing to provide supplemental oxygen to the patient while undergoing endotracheal intubation.
Device Description
The APA Oxy Blade is a laryngoscope blade intended to be used with the Venner Medical APA™ Video Laryngoscope. The APA Oxy Blade is a standard MacIntosh laryngoscope blade with the addition of an oxygen tube adaptor/holder and tubing to provide supplemental oxygen to the patient when using the Venner APA Video Laryngoscope. The Venner APA Video Laryngoscope, like other rigid laryngoscopes, provides a clear view of the upper airway (trachea/airway) and aids in the placement of an endotracheal tube for intubation.
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K Number
K163412Device Name
Girgis Scope Video 200 Double Bladed Laryngoscope (GSV200.DBL)
Manufacturer
Girgis Scope LLC
Date Cleared
2017-06-22
(199 days)
Product Code
CCW
Regulation Number
868.5540Why did this record match?
Product Code :
CCW
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Girgis Scope Video 200 Double Bladed Laryngoscope (GSV200.DBL) is indicated to improve direct visualization of larynx and assist in both non-complicated and difficult intubation of unpredictable airway condition.
Device Description
GSV200.DBL is designed to assist in tracheal intubation procedure by direct visualization of laryngeal anatomy in closed position and use movable blade with camera as accessory from different angle in open position. The physical shape of GSV200.DBL is a modification of traditional Macintosh blade similar to Propper flip tip laryngoscope with added movable blade with camera as accessory to provide visualization to insert endotracheal tube.
Girgis Scope Video DBL is designed to use two power sources, one in the stationary handle for fiber optic illumination of the airway and the second in the DVR monitor to illuminate the Larynx for the video camera. Battery chargers, cables to computer and cable to connect to TV screen are accessories included in the kit. The GSV200.DBL is provided non-sterile and is reusable and can be disassembled to provide cleaning and disinfection.
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K Number
K140951Device Name
YEESCOPE LARYNGOSCOPES
Manufacturer
YEESCOPE PTY. LTD.
Date Cleared
2014-11-10
(210 days)
Product Code
CCW
Regulation Number
868.5540Why did this record match?
Product Code :
CCW
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Yeescope laryngoscope is a single use, disposable laryngoscope blade and handle that is intended to facilitate and aid in tracheal intubation in a Magnetic Resonance (MR) environment, not to exceed a 3.0 Tesla static magnetic field.
Device Description
Yeescope laryngoscope blades and handles are single use, fully disposable laryngoscopes identical to our standard units except we have exchanged the battery to one that is less magnetic and thus would meet the requirements for MR conditional environments.
Yeescope laryngoscope are offered in one (1) style and two (2) sizes; Macintosh style (curved) and in Sizes 3 and 4.
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K Number
K121378Device Name
AIRTRAQ SP AIRTRAQ AVANT
Manufacturer
PRODOL MEDITEC LTD.
Date Cleared
2012-06-21
(44 days)
Product Code
CCW
Regulation Number
868.5540Why did this record match?
Product Code :
CCW
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Airtraq® SP - MR and Airtraq® Avant are intended to facilitate and aid in tracheal intubation in a Magnetic Resonance (MR) environment, not to exceed a 3.0 Tesla static magnetic field.
Device Description
Airtraq® Optical laryngoscope is an anatomical shaped rigid laryngoscope which allows the user to see the airway anatomy during insertion and intubation. It is designed with a guide channel in which one loads the endotracheal tube ("ET tube") that is then advanced once the glottis opening has been identified and centered in the view field of the Airtraq® optics. Prodol Meditec offers two (2) models.
Airtraq® SP - single patient
This model is a completely self-contained unit that operates on standard non-magnetic AAA batteries. It is a single patient use, disposable.
Airtraq® Avant
Avant once assembled is identical in its design and function as the Airtraq@ SP model.
Avant is designed as 2 components unlike the Airtraq® SP model.
1. Optics This is a limited life reusable components which contains the lenses and mirrors of the optical system plus the rechargeable, non-magnetic battery, and PCB which controls the LED light, heater and diagnostics for the battery.
2. Blade There are 2 blade sizes, Regular (ET tube size 7.0 mm to 8.5 mm) and Small (ET tube 6.0 mm to 7.5 mm). These are single use disposables in which the Optics are inserted and then the assembled device used. There is an eye cap that incorporates a protective lens that fits over the Optics once it has been inserted into the Blade.
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K Number
K063477Device Name
NOVAMED MRI CONDITIONAL LARYNGOSCOPE SET
Manufacturer
NOVAMED, LLC
Date Cleared
2007-02-09
(85 days)
Product Code
CCW
Regulation Number
868.5540Why did this record match?
Product Code :
CCW
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The NovaMed MRI Conditional laryngoscope set is used to facilitate and aid in tracheal intubation in a Magnetic Resonance (MR) environment, not to exceed a 3.0 Tesla static magnetic field.
Device Description
The NovaMed MRI Conditional laryngoscope handle, battery, and blades are standard blades and handles that have been specially treated to be useable in a magnetic resonance (MR) environment. Testing has been performed according to ASTM F2052-02 in a 3.0 Tesla environment. There are many handle and blade configurations offered.
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K Number
K062523Device Name
TRU-MR LARYNGOSCOPE SET
Manufacturer
TRUPHATEK INTERNATIONAL, LTD.
Date Cleared
2006-11-17
(81 days)
Product Code
CCW
Regulation Number
868.5540Why did this record match?
Product Code :
CCW
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Tru-MR TM laryngoscope set is used to facilitate and aid in tracheal intubation in a Magnetic Resonance (MR) environment, not to exceed a 3.0 Tesla static magnetic field.
Device Description
The Truphatek Tru-MRTM MR conditional laryngoscope handle, battery, and blades are standard blades and handles that have been specially treated to be useable in a magnetic resonance (MR) environment. Testing has been performed according to ASTM F2052-02 in a 3.0 Tesla environment. There are many handle and blade configurations offered.
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K Number
K062230Device Name
MR FIBER OPTIC INTUBATING LARYNGOSCOPE HANDLE, SHORT, MODEL 310002
Manufacturer
MINRAD, INC.
Date Cleared
2006-08-31
(29 days)
Product Code
CCW
Regulation Number
868.5540Why did this record match?
Product Code :
CCW
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MR MR MR Fiber Optic Intubating Laryngoscope Handle, Short ("MINRAD INC. MR Fiber Optic Intubating Laryngoscope Handle, Short") is used, together with a Laryngoscope blade, to facilitate and aid in tracheal intubation in a Magnetic Resonance Imaging (MRI) or an interventional Magnetic Resonance (MR) environment, not to exceed a 3.0 Tesla static magnetic field.
Device Description
MR Fiber Optic Intubating Laryngoscope Handle, Short
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K Number
K062231Device Name
MR FIBER OPTIC INTUBATING LARYNGOSCOPE HANDLE, STANDARD, MODEL 310001
Manufacturer
MINRAD, INC.
Date Cleared
2006-08-31
(29 days)
Product Code
CCW
Regulation Number
868.5540Why did this record match?
Product Code :
CCW
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MR Fiber Optic Intubating Laryngoscope Handle, Standard ("MINRAD INC. MR Fiber Optic Intubating Laryngoscope Handle, Standard") is used to facilitate and aid in tracheal intubation in a Magnetic Resonance Imaging (MRI) or an interventional Magnetic Resonance (MR) environment, not to exceed a 3.0 Tesla static magnetic field.
Device Description
The MR Fiber Optic Intubating Laryngoscope Handle, Standard
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K Number
K041852Device Name
MR TESTED FIBER OPTIC SHORT LARYNGOSCOPE HANDLE, MODEL 310002
Manufacturer
MINRAD, INC.
Date Cleared
2004-11-15
(130 days)
Product Code
CCW
Regulation Number
868.5540Why did this record match?
Product Code :
CCW
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MR Tested Fiber Optic Short Laryngoscope Handle ("MINRAD INC. MR Tested Fiber Optic Laryngoscope Handle") is used, together with a Laryngoscope blade, to facilitate and aid in tracheal intubation in a Magnetic Resonance Imaging (MRI) or an interventional Magnetic Resonance (MR) environment, not to exceed a 1.5 Tesla static magnetic field.
Device Description
Not Found
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K Number
K984101Device Name
FLEXIBLADE
Manufacturer
ARCO MEDIC LTD.
Date Cleared
1999-09-03
(290 days)
Product Code
CCW
Regulation Number
868.5540Why did this record match?
Product Code :
CCW
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Flexiblade™ - Flexible Laryngoscope is intended for use as an aid for placement of tracheal tube and examination and visualization of patient's upper airway.
Device Description
The Flexiblade™ is a rigid laryngoscope featuring a flexible blade. The flexibility of the blade is achieved as a result of the motion of a trigger on the larvngoscope handle that its front end is fixed to the front part of the blade and its rear end is free. This control over the blade flexibility allows the operator performing intubation to place the blade end exactly in the vallecula area elevating the epiglottis with his/her fingers (by gently squeezing the trigger) without changing the device position.
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