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The Gastric Port is intended to be used with an endoscope to facilitate intubation of the endoscope as a guide for various flexible endoscopic instruments for intraluminal procedures.

The safety and effectiveness of this device for Natural Orifice Transluminal Endoscopic Surgery (NOTES) has not been demonstrated.

Gastric Port Models GAP-0016-00, GAP-0018-00, GAP-0020-00

This document is a 510(k) substantial equivalence letter from the FDA to Apollo Endosurgery, Inc. regarding their Gastric Port device. It states that the device is substantially equivalent to legally marketed predicate devices.

This document does NOT contain information about acceptance criteria or a study proving device performance.

The letter establishes that the device can be legally marketed, subject to general controls and potentially additional controls if classified as Class II or III. It also outlines the indications for use, stating that the Gastric Port is intended to be used with an endoscope to facilitate intubation of the endoscope as a guide for various flexible endoscopic instruments for intraluminal procedures. It explicitly states that "The safety and effectiveness of this device for Natural Orifice Transluminal Endoscopic Surgery (NOTES) has not been demonstrated."

Therefore, I cannot provide the requested information from this document.

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