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FDA clearedFDA cleared. Stage 4 of 4 (Authorized)

FDA Clears Olympus Powerseal Open Extended Jaw Vessel Sealer for Open Surgery

The bipolar sealer and divider, cleared for open procedures on vessels up to 7 mm, is the fourth design in Olympus's Powerseal surgical energy line.

By News DeskApril 28, 20262 min read
A surgeon using an electrosurgical instrument during an operation
A surgeon using electrosurgical cautery to remove a lipoma. Not the Olympus POWERSEAL device described in this article. Jclemens, CC BY-SA 4.0, via Wikimedia Commons · CC BY-SA 4.0
FDA cleared510(k) · K252487FDA cleared. Stage 4 of 4 (Authorized)

The FDA cleared this device through the 510(k) pathway, which finds it substantially equivalent to a device already on the market. Clearance is not the same as approval.

Key points

  • The FDA cleared the POWERSEAL Open Extended Jaw Sealer and Divider under 510(k) K252487 on March 2, 2026; Olympus announced it on April 28.
  • The 510(k) summary names the LigaSure Impact as the predicate and says clinical studies were not necessary; bench and animal testing supported the submission.
  • Olympus said full US availability is expected in late spring 2026.

The US Food and Drug Administration has cleared Olympus's POWERSEAL Open Extended Jaw Sealer/Divider for use in open surgery, the company said in an April 28 release.

Vessel sealers use electrical energy to fuse and close blood vessels and tissue bundles, then cut them, in place of sutures or clips. The new device joins three 5 mm Powerseal instruments that Olympus already sells for open and laparoscopic procedures.

The 510(k) record

The FDA's 510(k) database lists the device as the POWERSEAL Open Extended Jaw Sealer and Divider, Double-Action (PS-0021EJDA), K252487. The applicant is Gyrus ACMI, Inc., of Westborough, Massachusetts, the town named in the dateline of Olympus's release. The agency received the traditional 510(k) on August 7, 2025, and found the device substantially equivalent on March 2, 2026. It sits under the electrosurgical cutting and coagulation product code and was reviewed by the general and plastic surgery panel.

According to the clearance letter and 510(k) summary, the device "is a bipolar electrosurgical instrument intended for use in open surgical procedures where ligation and division of vessels, tissue bundles, and lymphatics is desired." The predicate is the LigaSure Impact LF4418, cleared under K162047.

The summary says the device showed equivalent sealing performance to the predicate on measures including the 7 mm vessel sealing indication, seal time, burst pressure, thermal margin and tissue sticking. Testing included electrical, mechanical and functional bench work, surgeon input on design, and acute and chronic studies in pig and dog models. "Clinical studies were not necessary for the subject devices," the summary states.

Design claims and launch timing

Olympus said the device is designed to seal vessels up to and including 7 mm in diameter, including pulmonary vessels, along with tissue bundles and lymphatics. It said the open-surgery version adds a rotation knob placed near the handle for one-handed use, a wider range of rotation and a jaw coating designed to minimize tissue sticking.

The company cited internal data, including a survey in which it said 100% of surgeons reported being satisfied or very satisfied with reaching and rotating the jaws with one hand. Those figures are company data on file and were not independently reviewed.

"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," said Glenn Thurlow, vice president and regional business unit lead for surgical devices at Olympus Corporation of the Americas.

The release did not explain the eight-week gap between the FDA decision and the announcement. Olympus said it expects full market availability in late spring 2026 and did not give a price.

Sources

  1. Olympus Receives FDA Clearance for POWERSEAL Open Extended Jaw Device (company press release), Olympus Corporation of the Americas, April 28, 2026
  2. 510(k) K252487: POWERSEAL Open Extended Jaw Sealer and Divider, Double-Action (database record), US Food and Drug Administration, March 2, 2026
  3. K252487 clearance letter and 510(k) summary, US Food and Drug Administration, March 2, 2026