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510(k) Data Aggregation
K Number
K061663Device Name
ENDOMEDICAL TECHNOLOGIES QUIK-COVER FLEXIBLE ENDOSCOPE BARRIER SHEATH FOR OTOLARYNGOSCOPES AND BRONCHOSCOPES
Manufacturer
RTC INC.-MEMCATH TECHNOLOGIES LLC
Date Cleared
2006-09-06
(93 days)
Product Code
EOB
Regulation Number
874.4760Why did this record match?
Applicant Name (Manufacturer) :
RTC INC.-MEMCATH TECHNOLOGIES LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The EndoMedical Technologies Quik-Cover™ Flexible Endoscope Barrier Sheath provides a sterile, disposable protective covering for flexible endoscopes during endoscopic examination of the upper airway, vocal chords, nasal passages, esophagus and pulmonary structures,
Device Description
The EndoMedical Technologies Quik-Cover™ Flexible Endoscope Barrier Sheath (EndoMedical Technologies Quik-Cover™) is a sterile, single-use device that covers the entire patient contact surface of flexible endoscopes and eliminates the need for high-level disinfection of the endoscope following each procedure. The device is composed of a contiguous polymeric sheath, with an optical window at the distal end, which is preloaded on a deployment tube. Some models of the EndoMedical Technologies Quik-Cover™ include a Y-connector and side port channel(s) that are intended to allow passage of air, water, suction and biopsy instruments.
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K Number
K061324Device Name
EMT QUIK-COVER FLEXIBLE ENDOSCOPE BARRIER SHEATH, SERIES 1-7
Manufacturer
RTC INC.-MEMCATH TECHNOLOGIES LLC
Date Cleared
2006-06-20
(40 days)
Product Code
FED
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
RTC INC.-MEMCATH TECHNOLOGIES LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The EndoMedical Technologies Quik-Cover™ Flexible Endoscope Barrier Sheath provides a sterile, disposable protective covering for flexible endoscopes during endoscopic examination of bladder, urethra, lower gastrointestinal tract, and upper gastrointestinal structures including the esophagus.
Device Description
The EndoMedical Technologies Quik-Cover Flexible Endoscope Barrier Sheath (EndoMedical Technologies Quilt-Cover™) is a sterile, single-use device that covers the entire patient contact surface of flexible endoscopes and eliminates the need for high-level disinfection of the endoscope following each procedure. The device is composed of a contiguous polymeric sheath, with an optical window at the distal end which is preloaded on a deployment tube. Some models of the EndoMedival Technologies Quik-Cover™ include a Y-connector and side port channel(s) that are intended to allow passage of air, water, suction and biopsy instruments.
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