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Found 11 results
510(k) Data Aggregation
K Number
K110687Device Name
RELIEVA STRATUS PRO MICROFLOW SPACER (FRONTAL)
Manufacturer
ACCLARENT, INC.
Date Cleared
2011-10-07
(210 days)
Product Code
KAM
Regulation Number
878.4800Why did this record match?
Product Code :
KAM
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MicroFlow Spacer (Frontal) is indicated for use as a postoperative spacer to maintain an opening to the frontal sinuses within the first 14 days following surgery. The MicroFlow Spacer also helps to prevent obstruction.
Device Description
The Relieva Stratus Pro MicroFlow Spacer (Frontal) is a device that maintains an opening at the target sinus for up to 14 days postoperatively. The device can be manually removed during an office follow-up visit.
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K Number
K093594Device Name
MODIFICATION TO RELIEVA STRATUS MICROFLOW SPACER
Manufacturer
ACCLARENT, INC.
Date Cleared
2010-03-03
(104 days)
Product Code
KAM
Regulation Number
878.4800Why did this record match?
Product Code :
KAM
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MicroFlow Spacer (Frontal) is indicated for use as a postoperative spacer to maintain an opening to the frontal sinuses within the first 14 days following surgery. The MicroFlow Spacer also helps to prevent obstruction.
The MicroFlow Spacer (Ethmoid) is indicated for use as a postoperative spacer to maintain an opening to the ethmoid sinuses within the first 14 days following surgery. The MicroFlow Spacer also helps to prevent obstruction.
Device Description
The MicroFlow Spacer is a device that maintains an opening at the target sinus for up to 14 days postoperatively. There are two models of the MicroFlow Spacer: Ethmoid and Frontal. The modified device can be manually removed during an office follow-up visit at any time.
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K Number
K083574Device Name
RELIEVA STRATUS MICROFLOW SPACER
Manufacturer
ACCLARENT, INC.
Date Cleared
2009-01-29
(57 days)
Product Code
KAM
Regulation Number
878.4800Why did this record match?
Product Code :
KAM
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MicroFlow Spacer (Frontal) is indicated for use as a postoperative spacer to maintain an opening to the frontal sinuses within the first 14 days following surgery. The MicroFlow Spacer also helps to prevent obstruction.
Device Description
The Frontal Sinus Spacer is a device that maintains an opening at the frontal sinus for up to 14 days postoperatively. The subject device can be manually removed during an office follow-up visit at any time.
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K Number
K072891Device Name
SINUS SPACER
Manufacturer
ACCLARENT, INC.
Date Cleared
2008-03-19
(161 days)
Product Code
KAM
Regulation Number
878.4800Why did this record match?
Product Code :
KAM
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Sinus Spacer is indicated for use as a postoperative spacer to maintain an opening to the nasal sinuses within the first 14 days following surgery. The Sinus Spacer also helps to prevent obstructions.
Device Description
The Sinus Spacer is a device that maintains an opening at the intended sinus not to exceed 14 days postoperatively. The subject device can be manually removed during an office follow-up visit at any time.
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K Number
K073041Device Name
RELIEVA AND RELIEVA ACELLA SINUS BALLOON CATHETER
Manufacturer
ACCLARENT, INC.
Date Cleared
2008-03-11
(134 days)
Product Code
KAM
Regulation Number
878.4800Why did this record match?
Product Code :
KAM
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Relieva Sinus Balloon Catheter is an instrument intended to dilate sinus ostia and spaces within the paranasal sinus cavities for diagnostic and therapeutic procedures. For children aged 17 and under, the balloon catheter system is intended to dilate sinus ostia and spaces associated with the maxillary sinus for diagnostic and therapeutic procedures.
Relieva Acella Sinus Balloon Catheter is an instrument intended to dilate sinus ostia and spaces within the paranasal sinus cavities for diagnostic and therapeutic procedures. For children aged 17 and under, the balloon catheter system is intended to dilate sinus ostia and spaces associated with the maxillary sinus for diagnostic and therapeutic procedures.
Device Description
The Relieva Sinus Balloon Catheter is a catheter designed to dilate the sinus ostia and paranasal spaces in adults and maxillary sinus spaces in children.
The Relieva Acella Sinus Balloon Catheter is a catheter designed to access and to dilate the sinus ostia and paranasal spaces in adults and maxillary sinus spaces in children.
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K Number
K071845Device Name
RELIEVA LUMA SINUS ILLUMINATION SYSTEM, MODEL SIS-100A
Manufacturer
ACCLARENT, INC.
Date Cleared
2007-09-28
(85 days)
Product Code
KAM
Regulation Number
878.4800Why did this record match?
Product Code :
KAM
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Relieva Luma™ Sinus Illumination System is intended to provide a means to access the sinus space for diagnostic and therapeutic procedures in conjunction with other nasal and sinus products. It is also intended to illuminate within and transilluminate across nasal and sinus structures.
Device Description
The Relieva Luma™ Sinus Illumination System is a flexible device that transmits light at the distal tip. The system also contains two accessories: a light cable and an adapter.
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K Number
K062458Device Name
ETHMOID SINUS SPACER
Manufacturer
ACCLARENT, INC.
Date Cleared
2006-09-15
(23 days)
Product Code
KAM
Regulation Number
878.4800Why did this record match?
Product Code :
KAM
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Ethmoid Sinus Spacer is indicated for use as a postoperative spacer to maintain an opening to the ethmoid sinus within the first 14 days following surgery. The Ethmoid Sinus Spacer also helps to prevent obstruction.
Device Description
Not Found
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K Number
K060974Device Name
RELIENT NAVIGATION DEVICE
Manufacturer
ACCLARENT, INC.
Date Cleared
2006-05-05
(25 days)
Product Code
KAM
Regulation Number
878.4800Why did this record match?
Product Code :
KAM
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Sinus Guide Adapter and Calibration Device are intended to provide a means to access the sinus space for diagnostic and therapeutic procedures.
Device Description
The Sinus Guide Adapter is used to hold the Sinus Guide Catheter and the InstaTrak Receiver. The Sinus Guide Adapter is used in conjunction with a Calibration Device that is compatible with the InstaTrak Navigation system. The Calibration Device is used to calibrate the tip position and the trajectory line of the Sinus Guide Catheter. Once calibrated, the Calibration Device is removed.
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K Number
K050340Device Name
MICROMEDICS SPHENOID SINUS STENT
Manufacturer
MICROMEDICS, INC.
Date Cleared
2005-04-27
(75 days)
Product Code
KAM
Regulation Number
878.4800Why did this record match?
Product Code :
KAM
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Intended for use as a postoperative stent to maintain an opening to the sphenoid sinus, during the first 14 days following surgery and helps prevent obstruction by adhesions.
Device Description
Sphenoid Sinus Stent
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K Number
K994262Device Name
FRONTAL SINUS TREPHINATION CANNULA
Manufacturer
XOMED, INC.
Date Cleared
2000-02-08
(53 days)
Product Code
KAM, 77K
Regulation Number
878.4800Why did this record match?
Product Code :
KAM
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Frontal Sinus Trephination Cannula is indicated for patients with sinus disease that require frontal sinus irrigation or repeated frontal sinus irrigation for up to thirty days.
Device Description
The device consists of a cannula and an occlusion plug.
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