Reprocessed HARMONIC 700 Shears (HAR723/Reprocessed HARMONIC 700, 5mm Diameter Shears with Advanced Hemostasis x 23cm); Reprocessed HARMONIC 700 Shears (HAR736/Reprocessed HARMONIC 700, 5mm Diameter Shears with Advanced Hemostasis x 36cm); Reprocessed HARMONIC 700 Shears (HAR745/Reprocessed HARMONIC 700, 5mm Diameter SHears with Advanced Hemostasis x 45cm)

The Reprocessed HARMONIC 700 Shears are ultrasonic surgical instruments designed for soft tissue incisions with bleeding control and minimal thermal injury. Available in three shaft lengths (23cm, 36cm, 45cm), they can be used as an adjunct to or substitute for electrosurgery, lasers, and scalpels in general, pediatric, gynecologic, urologic, and thoracic procedures, and enable coagulation of vessels up to 7mm diameter using an Advanced Hemostasis hand control button.

The reprocessed device has identical design, materials, and intended use to the predicate HARMONIC 700 Shears. Key features include an actuating trigger, MIN/MAX control buttons for energy adjustment, an Advanced Hemostasis button for additional energy modes, a 360° rotatable shaft, and a torque wrench for hand piece attachment. The only difference is that some device components are replaced with equivalent components during reprocessing, and the device is sterilized to a 10-6 sterility assurance level via EO sterilization per ISO 11135.

Functional performance testing followed IEC 60601-1 and IEC 60601-1-2 for electrical safety and electromagnetic compatibility. Biocompatibility was evaluated per ISO 10993-1. Sterilization was performed in accordance with ISO 11135 (EO sterilization).

Substantial equivalence is established because the reprocessed device's design, materials, mechanism of action, and intended use are identical to the predicate HARMONIC 700 Shears. Bench and preclinical testing demonstrate the reprocessed device performs as safely and effectively as the predicate in all functional aspects including jaw clamp force, tissue retention, burst pressure, temperature, reliability, and hemostasis capability. No changes were made to sterilization processes or patient-contacting materials, and all previously validated biocompatibility information from the predicate remains applicable.