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510(k) Data Aggregation
K Number
K063654Device Name
ENDOGUIDE
Manufacturer
KMS MEDICAL LLC
Date Cleared
2007-01-31
(54 days)
Product Code
FDF
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
KMS MEDICAL LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The EndoGuide is intended to be used with an endoscope to facilitate intubation, change of endoscopes, and removal of multiple polyps and/or foreign bodies.
Device Description
The EndoGuide fits over a pediatric colonoscope and can be converted from a flexible to a rigid configuration on demand. The EndoGuide is back loaded onto the shaft of the colonoscope before the instrument is inserted into the patient. The device was designed to be activated by a vacuum source and needs to be connected to the existing vacuum line in the endoscopy suite. Application of vacuum causes the device to become rigid. In this "active" mode (vacuum on) the rigid insertion tube facilitates the passing of the colonoscope thru the insertion tube and resists colonoscope looping. In the "passive" mode (vacuum off) the insertion tube is very flexible and can be advanced deeper into the colon.
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