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The CRE™ Balloon Dilatation Catheter is indicated for use in adult and adolescent populations to endoscopically dilate strictures of the esophagus.

The proposed CRE™ Balloon Dilatation Catheter is capable of 3 distinct and progressively larger size diameters via controlled radial expansion. Specific balloon sizes are printed on each package and hub label. It is designed to be used through an endoscope having a 2.8mm or larger working channel. A stainless steel core wire extends through the entire length of the shaft. The wire is in tension within the balloon, which facilitates the removal of the catheter from the endoscope following balloon dilatation. The proposed device incorporates a minor material formulation change for the flexible tip of the device.

The Optical Dilator is indicated for dilation of strictures of the esophagus under endoscopic visualization.

The Ethicon Endo-Surgery Optical Dilator is a sterile, single-use disposable esophageal dilator for use with an endoscope to dilate esophageal strictures under endoscopic visualization. The Optical Dilator is made from a clear flexible polymer. An endoscope having an outer diameter of 10mm or less, such as a standard gastroscope, is positioned within the Optical Dilator to allow for visualization at the stricture site.

Used to dilate strictures of the gastrointestinal tract, including strictures of the esophagus, pylorus, duodenum and colon.

The modified Hercules 3 Stage Wire Guided Balloon consists of coaxial catheter with a dilation balloon mounted on the distal tip. The balloon is inflatable with fluid to three distinct and progressively larger size diameters to exert pressure on strictures and affect dilation of the stricture. It is offered in a variety of balloon diameters. Supplied sterile and Intended for Single Use. Inflation device sold separately.

The SMART Dilator is indicated for dilation of strictures of the esophagus under endoscopic visualization in adults 18 years or older.

The SMART Dilator is a sterile, single use disposable esophageal dilator. The SafeStitch endoscope guide dilator consists of a graduated tube with a center endoscope channel, a tapered tip and a safety handle. The flexible endoscope has a relative rigidity and in combination with the dilator will provide sufficient axial integrity for dilation. The handle provides feedback to indicate how much axial force is being placed on the device and subsequently, the esophagus.

The Esophageal Balloon Dilator is used to endoscopically dilate strictures of the esophagus.

The proposed Cook Endoscopy Dilation Balloon is a single lumen catheter with a balloon mounted on the distal tip. The balloon is inflatable with water to three distinct and progressively larger size diameters to exert force on esophageal strictures resulting in stricture dilation. It is offered in a variety of diameters to accommodate a range of esophageal strictures This device is supplied sterile and intended for single use. This balloon is not sold with inflation device.

The Boston Scientific Corporation Maxforce TTS Single-Use Balloon Dilator is indicated for use in adults and adolescent populations to endoscopically dilate strictures of the esophagus.

The Maxforce TTS Single-Use Balloon Dilator consists of a distal tip, balloon, catheter shaft, and proximal hub.

The InScope Precision Balloon Dilator - Wire Guided - with pre-loaded 0.035" guide wire - Is a sterile, single use, disposable dilator used in the alimentary tract (esophagus, pylorus and colon). In the sterile product packaging also a stopcock is provided to maintain pressure or vacuum by an inflation device. The balloon specific pressure / diameter relationship is represented on the labeling of each product. The InScope Precision Balloon Dilator is intended for use in adult and adolescent populations to endoscopically dilate strictures of the alimentary tract (i.e. esophagus, pylorus and colon).

The subject InScope Precision Balloon Dilator - Wire Guided described in this submission is virtually identical to its predicate device(s), which already have received 510(k) concurrence. Compared to the previously cleared predicate device - InScope Precision Balloon Dilator - Fixed Wire, the subject InScope Precision Balloon Dilator - Wire Guided in this submission now resembles the Boston Scientific's CRE Wireguided Balloon Dilator, which already received FDA 510(k) concurrence.

The InScope™ Precision Balloon Dilator is intended for use in adult and adolescent populations to endoscopically dilate strictures of the esophagus.

The InScope Precision Balloon Dilator is a sterile, single use, disposable esophageal dilator. The InScope Precision Balloon Dilator contains three marking bands on the balloon to facilitate more precise centering the balloon within the stricture. The middle band is located at the center of the balloon at 5 cm distance from the shaft marker. The proximal and distal bands are set 2.5 cm from the centre band. The InScope Precision Balloon Dilator is provided with a stopcock to maintain pressure or vacuum. The InScope Precision Balloon Dilator is capable of 3 distinct and progressive larger diameters as a function of the applied inflation pressure. The specific pressure / diameter relationship is represented on the labeling of each product. The subject InScope Precision Balloon Dilator described in this submission is virtually identical to its predicate device (Boston Scientific's CRE Balloon dilatation catheter), which already has received FDA 510(k) concurrence.

To dilate strictures of the GI tract including the colon, pylorus and esophagus.

The Bard® ELIMINATOR® PET Balloon Dilators are comprised of a radioopaque polyurethanc catheter with an internally fixed guide wire and a high-pressure nondistending PET balloon.

The Optical DVS (Dual Vector Shearing) Esophageal Dilator is indicated for dilation of strictures of the esophagus under endoscopic visualization.

The Optical DVS is a sterile, single use, disposable esophageal dilator for use with an endoscope to dilate esophageal strictures under endoscopic visualization. The Optical DVS is made from a clear flexible polymer. An endoscope having an outer diameter of 10mm or less, such as a standard gastroscope, is positioned within the Optical DVS to allow for visualization at the stricture site.