Search Results

The Scion Balloon Elevator is designed for endoscoopic surgery involved in extraperitoneal or subcutaneous spaces in such common procedures as Saphenous Vein Harvest. The Balloon elevator is designed to fit on the end of our Endoscope Retractor (510K #93006) and atraumatically provide support for the distal end of the retractor. The other function of the balloon is to gently spread tissue by the inflation of the balloon.

Not Found

The provided text is a 510(k) clearance letter from the FDA for a device called "Scion Balloon Elevator." This document does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, ground truth establishment, or any other details related to the evaluation of the device's technical capabilities or clinical effectiveness.

The letter focuses solely on the regulatory approval process, stating that the device is substantially equivalent to legally marketed predicate devices and therefore can be marketed.

Therefore, I cannot provide the requested information based on the input text.

Ask a specific question about this device