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510(k) Data Aggregation
K Number
K032688Device Name
COLONOSIGHT MODEL 510B
Manufacturer
SIGHTLINE TECHNOLOGIES LTD.
Date Cleared
2004-03-05
(189 days)
Product Code
FDF
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
SIGHTLINE TECHNOLOGIES LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ColonoSight Model 510B is intended to provide visualization (via a video monitor) and therapeutic access to the lower gastrointestinal tract. The lower gastrointestinal tract includes, but is not restricted to, the organs, tissues, and subsystems of the large bowel. The device is introduced rectally as with any standard colonoscope, when indications consistent with the requirement for the procedure are observed in adult patient populations.
Device Description
The ColonoSight is a colonoscope covered with a disposable protective sheath and incorporating disposable channels for protective oncain and suction/therapeutic interventions. Intubation, is perfomed using an "air assisted push technology". The main components are: EndoSight, Camera Contol Unit, Hydro-The main componentie t; disposable ColonoSleeve and disposable Hub.
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K Number
K011825Device Name
RECTOSIGHT RS300-04;AND PROTOSIGHT PS300-04 DEVICE
Manufacturer
SIGHTLINE TECHNOLOGIES LTD.
Date Cleared
2001-07-11
(30 days)
Product Code
FER
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
SIGHTLINE TECHNOLOGIES LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The RectoSight® RS300-04 device is a video sigmoidoscope device intended to provide optical visualization of, and therapeutic access to the rectal cavity. The instrument contains channels for insufflation, irrigation and surgical procedures.
The ProctoSight® PS310-04 device is a video sigmoidoscope device intended to provide optical visualization of, and therapeutic access to the rectal cavity. The instrument contains channels for insufflation, irrigation and surgical procedures.
Device Description
Not Found
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K Number
K994130Device Name
RECTOSIGHT RS 300-04
Manufacturer
SIGHTLINE TECHNOLOGIES LTD.
Date Cleared
2000-06-30
(206 days)
Product Code
FER
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
SIGHTLINE TECHNOLOGIES LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The RectoSight® RS 300-04 is a video sigmoidoscope device intended to provide optical visualization of, and therapeutic access to the rectal cavity. The instrument contains channels for insufflation, irrigation and surgical procedures. The ProctoSight® PS 300-04 is a video sigmoidoscope device intended to provide optical visualization of, and therapeutic access to the anal cavity. The instrument contains channels for insufflation, irrigation and surgical procedures.
Device Description
Not Found
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