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Found 8 results
510(k) Data Aggregation
K Number
K163247Device Name
3.3 mm Laurimed Microdebrider; 4.0 mm Laurimed Microdebrider
Manufacturer
Date Cleared
2017-03-09
(111 days)
Product Code
Regulation Number
874.4250Why did this record match?
Applicant Name (Manufacturer) :
LAURIMED LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The PolypVac Microdebrider is a shaver system intended for the resection of soft tissue and thin bone as part of the following endoscopic sinus procedures: ethmoidectomy, maxillary antrostomy, polypectomy, turbinectomy / turbinate reduction, sphenoidotomy, and frontal recess dissection.
Device Description
The PolypVac Microdebrider is a shaver system intended for the resection of soft tissue and thin bone as part of endoscopic sinus procedures. The system consists of a hand-held cutting device, tissue filter, and stylet. The PolypVac Microdebrider is supplied sterile and is single-use and disposable.
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K Number
K161101Device Name
PolypVac Microdebrider (3.3mm and 4.0mm)
Manufacturer
Date Cleared
2016-06-22
(64 days)
Product Code
Regulation Number
874.4250Why did this record match?
Applicant Name (Manufacturer) :
LAURIMED LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Indicated for the excision of polyps in the nasal passageways and in sinuses for which access has been previously established.
Device Description
The Laurimed PolypVac Microdebrider is intended for cutting and aspirating polyp tissue during sinus and nasal procedures. The system consists of a hand-held cutting device, tissue filter, and stylet. The PolypVac Microdebrider is supplied sterile and is single-use and disposable.
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K Number
K133133Device Name
LAURIMED POLYPVAC MICRODEBRIDER
Manufacturer
Date Cleared
2013-12-23
(84 days)
Product Code
Regulation Number
874.4250Why did this record match?
Applicant Name (Manufacturer) :
LAURIMED LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Indicated for the excision of polyps in the nasal passageways and in sinuses for which access has has been previously established.
Device Description
The Laurimed PolypVac Microdebrider is intended for cutting and aspirating polyp tissue during sinus and nasal procedures. The system consists of a hand-held cutting device and device cleaner. The PolypVac Microdebrider is supplied sterile and is single-use and disposable.
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K Number
K091818Device Name
LAURIMED SPINAL INJECTION SYSTEM
Manufacturer
Date Cleared
2009-09-23
(97 days)
Product Code
Regulation Number
868.5150Why did this record match?
Applicant Name (Manufacturer) :
LAURIMED LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The TruCath Spinal Injection System is indicated for use in injections into the epidural space. Not for use with other catheters or needles.
Device Description
The Trucath Spinal Injection System integrates a flexible Catheter with an atraumatic distal tip into a Needle designed for use in injections into the epidural space of the spine. The Trucath Spinal Injection System is supplied as a sterile, single patient use, disposable device.
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K Number
K090815Device Name
PERCUTANEOUS DISCECTOMY SYSTEM
Manufacturer
Date Cleared
2009-05-21
(57 days)
Product Code
Regulation Number
888.1100Why did this record match?
Applicant Name (Manufacturer) :
LAURIMED LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Laurimed Discectomy System is indicated for use in aspiration of disc material during open discectomies in the lumbar region of the spine.
Device Description
The Laurimed Discectomy System is intended to be used to cut and aspirate nucleus material from discs in the spine. The system consists of a set of introduction tools (Dilator, Straight Cannula, Curved Cannula (qty. 2) and Trocar), a Device Cleaner, and a Discectomy Device
The Laurimed Discectomy System is supplied as a sterile, single patient use, single-level, disposable device.
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K Number
K083909Device Name
SPINAL INJECTION SYSTEM
Manufacturer
Date Cleared
2009-03-18
(78 days)
Product Code
Regulation Number
868.5150Why did this record match?
Applicant Name (Manufacturer) :
LAURIMED LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Laurimed Spinal Injection System is intended for use in procedures where injection is required.
The Laurimed Spinal Injection System is indicated for use in spinal epidural iniections for the administration of contrast media, anesthetic agents to provide regional anesthesia, and anti-inflammatory medications. Not for use with other needles or catheters.
Device Description
The Laurimed Spinal Injection System integrates a flexible Catheter with an atraumatic distal tip into a Needle designed for injections/infusions of contrast media, anesthetics, and anti-inflammatory medications into the epidural space of the spine.
The Spinal Injection System is supplied as a sterile, single patient use, disposable device.
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K Number
K082194Device Name
LAURIMED PERCUTANEOUS DISCECTOMY SYSTEM, MODEL FG-000002
Manufacturer
Date Cleared
2008-08-28
(24 days)
Product Code
Regulation Number
888.1100Why did this record match?
Applicant Name (Manufacturer) :
LAURIMED LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Laurimed Percutaneous Discectomy System is indicated for use in aspiration of disc material during percutaneous discectomies in the lumbar region of the spine.
Device Description
The Laurimed Percutaneous Discectomy System is intended to be used to cut and aspirate nucleus material from discs in the spine. The system consists of a set of introduction tools (Introducer Needle with Stylet, Guidewire, Dilator, Cannula, Trocar, and Cannula Clamp), a Device Cleaner, and a Discectomy Device. The Laurimed Percutaneous Discectomy System is supplied as a sterile, single patient use, single-level, disposable device.
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K Number
K080140Device Name
LAURIMED SPINAL INJECTION SYSTEM
Manufacturer
Date Cleared
2008-05-09
(108 days)
Product Code
Regulation Number
868.5150Why did this record match?
Applicant Name (Manufacturer) :
LAURIMED LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Laurimed Spinal Injection System is intended for use in procedures where injection is required.
The Laurimed Spinal Injection System is indicated for use in spinal epidural injections for administration of anesthetic agents to provide regional anesthesia. Not for use with other needles or catheters.
Device Description
The Laurimed Spinal Injection System integrates a flexible Catheter with an atraumatic distal tip into a Needle designed for injections/infusion of local anesthetics into the epidural space of the spine.
The Spinal Injection System is supplied as a sterile, single patient use, disposable device.
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