AEON™ Endoscopic Powered Stapler

The AEON Endoscopic Powered Stapler is a surgical device that places two triple-staggered rows of titanium staples while simultaneously cutting tissue. It is used in general, abdominal, gynecologic, pediatric, and thoracic surgery for resection, transection, and creation of anastomoses, including specific applications to liver, pancreas, kidney, and spleen tissue. The powered handle is reloadable up to 20 times per procedure and is available in three lengths with multiple staple sizes.

The subject device is identical to the reference device (K234039) in design, materials, software, electrical requirements, packaging, and performance. Like the predicate, it uses the same reloads with identical tissue stops, anvils, cutting mechanisms, staple heights, and sterilization methods. The key difference from the predicate (K222210) is that the subject device is powered rather than manual and contains software, matching the reference device's operational principle.

Not stated in this summary. The document references IEC/EMC electrical requirements and MR safety information but does not cite specific ISO, IEC, or ASTM standards by number.

The subject device shares identical design, materials, technological characteristics, and performance specifications with the reference device K234039, which has already been cleared. Because the subject device is physically and functionally identical to K234039, no additional biocompatibility, sterilization validation, software validation, or electrical safety testing was required. The expansion of indications to include thoracic applications is supported by real-world clinical evidence demonstrating safety and effectiveness in that surgical application, making it substantially equivalent to the predicate for the expanded indications.