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The JetPrep Flushing Device is intended for use as a flexible endoscopic accessory to apply legally marketed solutions for washing mucosal tissue in the gastrointestinal tract.

The JetPrep Flushing Device is a sterile, disposable, single use device, intended for use as flexible endoscopic accessory to apply legally marketed solutions for washing mucosal tissue in the gastrointestinal tract. The device is composed of a catheter with a spray tip on its distal tip. During operation, the catheter should be inserted into the endoscope working channel. The spray tip location can be manually controlled by the user to be positioned on the distal end of the endoscope working channel, and thus apply a funnel shaped irrigation spray pattern. The device does not impede aspiration of debris and fluids through the endoscope working channel while it remains within the endoscope. For providing irrigation fluids, the device should be connected to legally marketed irrigation pumps or manual syringe for endoscopy. This 510(k) notice adds an additional model of the device.

The JetPrep Flushing Device is intended for use as a flexible endoscopic accessory to apply legally marketed solutions for washing mucosal tissue in the gastrointestinal tract.

The JetPrep Flushing Device is a sterile, disposable, single use device, intended for use as flexible endoscopic accessory to apply legally marketed solutions for washing mucosal tissue in the gastrointestinal tract. The device is composed of a catheter with a spray tip on its distal tip. During operation, the catheter should be inserted into the endoscope working channel. The spray tip location can be manually controlled by the user to be positioned on the distal end of the endoscope working channel, and thus apply 360 degree irrigation spray pattern. The device does not impede aspiration of debris and fluids through the endoscope working channel while it remains within the endoscope. For providing irrigation fluids, the device should be connected to legally marketed irrigation pumps or manual syringe for endoscopy.