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510(k) Data Aggregation
K Number
K080050Device Name
SPIRUS MEDICAL ENDO-EASE ENDOSCOPIC OVERTUBE
Manufacturer
SPIRUS MEDICAL, INC.
Date Cleared
2008-05-06
(119 days)
Product Code
FED, FDA
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
SPIRUS MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Spirus Medical, Inc. Endo-Ease Endoscopic Overtube is indicated to aid endoscopic insertion and advancement to the mid-ileum using during diagnostic and therapeutic upper GI endoscopy and enteroscopy. The Endo-Ease is used with an endoscope of appropriate diameter and length (such as an enteroscope or pediatric colonoscope).
Device Description
The device described in this 510(k) consists of a modified sterile, single use, flexible overtube designed for use with currently marketed flexible endoscopes in the lower GI tract.
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K Number
K080042Device Name
SPIRUS MEDICAL SURGICAL INSTRUMENT
Manufacturer
SPIRUS MEDICAL, INC.
Date Cleared
2008-04-03
(86 days)
Product Code
KMJ, FDA
Regulation Number
880.6375Why did this record match?
Applicant Name (Manufacturer) :
SPIRUS MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Intended for medical purposes to lubricate body orifices to facilitate entry of diagnostic or therapeutic devices.
Device Description
The Spirus Medical Lubricant is a water-based lubricant intended for lubrication of a body orifice to facilitate entry of a diagnostic or therapeutic device.
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K Number
K062805Device Name
MODIFICATION TO ENDO-EASE
Manufacturer
SPIRUS MEDICAL, INC.
Date Cleared
2006-10-13
(24 days)
Product Code
FED
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
SPIRUS MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Spirus Medical, Inc. Endo-Ease Endoscopic Overtube is indicated for use with a flexible endoscope to aid in endoscopic insertion and advancement during diagnostic and therapeutic lower GI flexible endoscopy.
Device Description
The device described in this 510(k) consists of a a modified sterile, single use, flexible over ube designed for use with currently marketed flexible endoscopes in the lower GI tract.
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K Number
K060235Device Name
ENDO-EASE ENDOSCOPIC OVERTUBE
Manufacturer
SPIRUS MEDICAL, INC.
Date Cleared
2006-08-04
(186 days)
Product Code
FDA
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
SPIRUS MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Spirus Medical, Inc. Endo-Ease Endoscopic Overtube is indicated to aid endoscopic insertion and advancement to the mid-jejunum during diagnostic and therapeutic upper GI endoscopy. The Endo-Ease is used with an endoscope of appropriate diameter and length (such as an enteroscope or pediatric colonoscope).
Device Description
The device described in this 510(k) consists of a sterile, single use, flexible overtube designed for use with currently marketed flexible endoscopes in the upper GI tract.
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K Number
K052084Device Name
ENDO-EASE ENDOSCOPIC OVERTUBE
Manufacturer
SPIRUS MEDICAL, INC.
Date Cleared
2005-09-14
(43 days)
Product Code
FED, KOG
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
SPIRUS MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Spirus Medical, Inc. Endo-Ease Endoscopic Overtube is indicated for use with a flexible endoscope to aid in endoscopic insertion and advancement during diagnostic and therapeutic lower GI flexible endoscopy.
Device Description
The device described in this 510(k) consists of a sterile, single use, flexible overtube designed for use with currently marketed flexible endoscopes in the lower & I tract.
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