FDA OKs Olympus’ Powerseal Extended Jaw Sealer/Divider

Olympus has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Powerseal open extended jaw sealer/divider for use in open surgery.

The bipolar electrosurgical instrument is indicated for open procedures where ligation and division of vessels, tissue bundles, and lymphatics is desired. It’s meant for single use only and the company advised not to re-sterilize due to risks like cross-contamination and excessive wear and degradation.

The new instrument joins three 5 mm devices in the Powerseal portfolio. The 5 mm devices are offered in three jaw configurations, each available in three shaft lengths, to supports surgeons’ preference and technique for dissection, grasping, and sealing during open and laparoscopic surgical procedures.

The Powerseal portfolio is indicated for use in general surgery, gynecological, colorectal, bariatric, urological, thoracic, and vascular.

The Powerseal open extended jaw was designed for confident vessel sealing in vessels up to and including 7 mm in diameter including pulmonary vessels, tissue bundles, and lymphatics. Multifunctional jaw capabilities support the many ways surgeons may use vessel sealing devices including spot coagulation, cold cutting, atraumatic grasping, and dissecting.

A proximally located rotation knob supports single-handed use, increased range of rotation for efficiency and control, and a jaw coating was designed to minimize tissue sticking. Full market availability is expected in late Spring 2026.

“We are pleased to receive 510(k) clearance for the POWERSEAL Open Extended Jaw for open surgery, further expanding our advanced bipolar surgical energy portfolio,” said Glenn Thurlow, VP and regional business unit lead for Surgical Devices at Olympus Corporation of the Americas. “The POWERSEAL devices are designed to address physician needs for strong vessel sealing, procedural efficiency, and comfort in the operating room, supporting our ongoing commitment to advancing surgical performance and patient care.”