WESTBOROUGH, MASSACHUSETTS, April 28, 2026
Olympus Corporation has received FDA 510(k) clearance for its latest innovation, the POWERSEAL™ Open Extended Jaw Sealer/Divider, expanding its advanced bipolar surgical energy portfolio and reinforcing its leadership in precision surgical technologies. The newly cleared device is designed for open surgical procedures, offering enhanced control, efficiency, and vessel sealing performance, and is expected to be commercially available in the United States by late Spring 2026. This milestone highlights Olympus’ continued commitment to improving surgical outcomes and advancing minimally invasive and open surgical care through cutting-edge medical devices.
Advanced Surgical Energy Technology for Precision and Control
The POWERSEAL Open Extended Jaw is a next-generation bipolar electrosurgical instrument engineered to support ligation and division of vessels, tissue bundles, and lymphatics during open surgery. The device is capable of delivering reliable vessel sealing for vessels up to 7mm in diameter, including pulmonary vessels, making it suitable for a wide range of complex surgical applications.
It integrates multifunctional jaw capabilities, enabling surgeons to perform spot coagulation, atraumatic grasping, cold cutting, and tissue dissection with a single instrument, thereby improving operating room efficiency and workflow optimization. The addition of this device complements Olympus’ existing portfolio of 5mm POWERSEAL devices, which are widely used across general, gynecological, colorectal, bariatric, urological, thoracic, and vascular surgeries, further strengthening its position in energy-based surgical solutions.
Enhanced Ergonomics and Surgeon-Centric Design
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A key innovation of the POWERSEAL Open Extended Jaw device lies in its ergonomic design and usability enhancements, which are critical for improving surgeon performance during prolonged procedures. The device features a proximally located rotation knob, enabling single-handed operation, along with an increased range of rotation for better maneuverability and precision in confined surgical spaces. Additionally, the instrument includes a specialized jaw coating designed to minimize tissue sticking, reducing interruptions and improving procedural consistency.
These features collectively contribute to reduced hand fatigue, improved tactile control, and enhanced surgical precision, addressing long-standing challenges in open surgical procedures. By focusing on surgeon comfort and operational efficiency, Olympus continues to align product innovation with real-world clinical needs.
Expanding MedTech Innovation and Regulatory Milestones
The FDA’s 510(k) clearance pathway validates that the POWERSEAL Open Extended Jaw device meets stringent safety and performance standards, allowing it to be marketed in the U.S. healthcare system. This regulatory milestone reflects Olympus’ strong adherence to quality and compliance frameworks, including Good Manufacturing Practice (GMP) and medical device regulatory standards. The introduction of this fourth design in the POWERSEAL portfolio demonstrates Olympus’ strategy to expand its surgical energy offerings and provide clinicians with versatile, high-performance tools tailored to different surgical techniques and preferences.
As hospitals and surgical centers increasingly adopt advanced energy devices, the demand for solutions that deliver precision, efficiency, and reliability continues to grow. With this latest clearance, Olympus is well positioned to drive innovation in surgical technology, enhance patient safety, and support better clinical outcomes across multiple specialties.
Source: Olympus press release
