Olympus Receives FDA Clearance for POWERSEAL™ Open Extended Jaw Device

Fourth Design Introduced in the POWERSEAL Advanced Bipolar Surgical Energy Portfolio Offers Surgeons an Additional Option for Open Surgery

WESTBOROUGH, Mass., (April 28, 2026) - Olympus Corporation, a global medical technology company committed to making people's lives healthier, safer, and more fulfilling, announced today it has received FDA 510(k) clearance from the U.S. Food and Drug Administration for the POWERSEAL™ Open Extended Jaw Sealer/Divider for use in open surgery.

The POWERSEAL Open Extended Jaw Sealer/Divider joins three 5mm devices in the POWERSEAL portfolio. These 5 mm devices are offered in three jaw configurations, each available in three shaft lengths, to support surgeon preference and technique for dissection, grasping, and sealing during open and laparoscopic surgical procedures. The POWERSEAL portfolio is indicated for use by numerous surgical specialties including General Surgery, Gynecological, Colorectal, Bariatric, Urological, Thoracic, and Vascular.1

Like the 5mm devices in the POWERSEAL portfolio, the POWERSEAL Open Extended Jaw is designed to deliver:

• Confident vessel sealing in vessels up to and including 7mm in diameter including pulmonary vessels, tissue bundles, and lymphatics²
• Multifunctional jaw capabilities that support the many ways surgeons may use vessel sealing devices including spot coagulation, cold cutting, atraumatic grasping and dissecting³
• Improved ergonomics that support reduced hand fatigue and promote ease of use for the surgeon.⁴

Unique features of the POWERSEAL™ Open Extended Jaw that support the need for precision, efficiency, and control during open surgery include a proximally located rotation knob to support single-handed use,5 increased range of rotation for efficiency and control,6 and a jaw coating designed to minimize tissue sticking.7

"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, Vice President 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."

Full market availability for the new POWERSEAL Open Extended Jaw device is expected in late Spring 2026.

For more information about the POWERSEAL family of devices, visit OlympusAmericaMarketing.com/Powerseal OEJ.

The POWERSEAL™ Open Extended Jaw Sealer & Divider (PSOEJ) is a bipolar electrosurgical instrument indicated for use in open surgical procedures where ligation and division of vessels, tissue bundles, and lymphatics is desired. The PSOEJ device is intended for single use only and re-sterilization is not advised due to risks such as cross-contamination and excessive wear and degradation. PSOEJ has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Consult with a qualified professional prior to utilizing PSOEJ on patients who have electronic implants to avoid possible hazard. For complete indications, contraindications, warnings, and cautions, please reference the full Instructions for Use (IFU) that accompanies the products.

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About Olympus
At Olympus, we are committed to Our Purpose of making people's lives healthier, safer and more fulfilling. As a global medical technology company, we partner with healthcare professionals to provide innovative solutions and services for early detection, diagnosis and minimally invasive treatment, aiming to improve patient outcomes by elevating the standard of care in targeted disease states.

For more than 100 years, Olympus has pursued a goal of contributing to society by producing products designed with the purpose of delivering optimal outcomes for its customers around the world. For more information, visit the Olympus website and follow the Olympus LinkedIn account.

References

¹IFU PN0040180, PN0021437

²Data on file with Olympus (DN0067640, DN0067559)

³Data on file with Olympus (DN0067230, DN0068748, DN0070939)

⁴Data on file with Olympus (DN0067230, DN0068748)

⁵100% of surgeons surveyed indicated they were Satisfied (30%) or Very Satisfied (70%) reach & rotate the POWERSEAL™ Open Extended Jaw jaws with one hand. Data on file with Olympus (DN0067230)

⁶Data on file with Olympus (DN0067230)

⁷Data on file with Olympus (DN0070939)