Dexter L6 System

The Dexter L6 System is a robotic surgical system that assists surgeons in performing minimally invasive laparoscopic procedures. It enables precise control of endoscopes and surgical instruments for tissue manipulation including grasping, suturing, dissecting, coagulating, and cutting. The system is intended for laparoscopic inguinal hernia repair and cholecystectomy in adults 22 years and older, operated by trained laparoscopic or robotic surgeons in an operating room.

The subject device has identical technological characteristics to the predicate Dexter L6 System (DEN230084). It comprises a surgeon console with handle grips and foot pedals, two patient carts positioned at the operating table, fully articulated single-use instruments (needle holder, graspers, dissectors, scissors, hook), and sterile/reusable accessories. The only changes are labeling modifications to clarify cholecystectomy use, suturing capability, and contraindications.

Not stated in this summary.

The device is substantially equivalent because it is physically and functionally identical to the predicate device with no hardware or software modifications—only labeling changes. The NEST clinical study of 51 cholecystectomy patients demonstrated 98% successful procedure completion with one conversion, one postoperative adverse event, and two intraoperative adverse events, all resolved and unrelated to the device. This clinical performance mirrors the predicate's safety and effectiveness profile, and since the expanded indications (adding cholecystectomy and suturing clarification) do not alter the device's fundamental operation or risk profile, substantial equivalence is established.