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510(k) Data Aggregation
K Number
K183171Device Name
ScopeSeal Duodenoscope Protective Device
Manufacturer
GI Scientific LLC
Date Cleared
2019-10-08
(326 days)
Product Code
ODB, FDT, FEI
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
GI Scientific LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
When properly installed: (i) the ScopeSeal® Duodenoscope Protective barrier at the scope's distal end to significantly reduce the level of contamination of the distal end during use and prior to reprocessing, and (ii) the ScopeSeal®'s working channel also provides a protective barrier sealing the duodenoscope's elevator area during use, and (iii) the ScopeSeal® device provides an additional protective benefit after use when kept in place during the ScopeSeal Pre-Cleaning Procedure™ performed after use.
The ScopeSeal® is compatible for use with the Olympus Duodenoscope Model TJF-Q180V.
Device Description
The GI Scientific ScopeSeal® Duodenoscope Protective Device is provided as a sterile, single-use device that attaches to the distal end of a duodenoscope. When properly installed the device creates a protective barrier or shield that seals the distal end of the duodenoscope to protect it from contamination during the procedure. The device is designed to preserve the mechanical and optical functionality of the duodenoscope. The ScopeSeal® Duodenoscope Protective Device includes a flexible Working Channel Extension™ that seals against the end of the duodenoscope's working channel, providing a sealed, passageway from the end of the duodenoscope's working channel through the ScopeSeal® device's working channel extension and out to the patient's gastrointestinal tract. This element of ScopeSeal®'s design allows instruments to be passed down the duodenoscope's working channel, through the ScopeSeal® device's Working Channel Extension™, and out to the patient's gastrointestinal tract, without instruments coming into contact with the duodenoscope's elevator, effectively sealing over the elevator area of the duodenoscope. The ScopeSeal® allows passage of device up to 10.7Fr (3.5mm) in diameter.
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K Number
K140295Device Name
GIS ENDOSCOPIC OPTICAL LENS
Manufacturer
GI SCIENTIFIC LLC
Date Cleared
2014-07-24
(168 days)
Product Code
FDS
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
GI SCIENTIFIC LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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