LYNX COBLATION Laryngeal Wand (72290254)

The LYNX COBLATION Laryngeal Wand is a single-use, disposable electrosurgical device for ablation, resection, and coagulation of soft tissues and hemostasis of blood vessels in ENT procedures of the larynx and trachea. It operates in bipolar radiofrequency mode using conductive irrigating solution and integrates suction, saline delivery, and an electrical cable into the handpiece for use with WEREWOLF COBLATION System controllers.

The LYNX Wand differs from the predicate PROCISE LW Wand in working length (10 inches vs. 8 inches), electrode orientation (10° away from user vs. 45° toward user), distal bend angle (25° vs. 16°), and proximal bend angle (25° vs. 45°). It adds use-limiting and embedded software features similar to the reference HALO Wand. Both use bipolar configuration, integrated lines, foot-pedal activation, and ethylene oxide sterilization with similar electrode components and tissue-contact duration.

ISO 10993-1 for biocompatibility (cytotoxicity, sensitization, irritation, chemical characterization); IEC 60601-1 and IEC 60601-2-2 for electrical safety; IEC 60601-1-2 for electromagnetic compatibility; AAMI TIR28:2016/(R)2024 for sterilization validation; and FDA Guidance for Electrosurgical Devices (March 9, 2020).

The LYNX Wand is substantially equivalent to the PROCISE LW Wand because it shares the same intended use, principle of operation (bipolar coblation), fundamental scientific technology, performance characteristics, and regulatory classification. Design differences in angle and length are ergonomic improvements that do not alter safety or effectiveness. Ex vivo testing on bovine myocardial tissue and clinical history of coblation technology in laryngeal/tracheal applications support safety and effectiveness parity with the predicate.