WHERE ARE YOU?

Concept Pre-Sub Submission prep Newly cleared Raising Postmarket & security

THE TAPE

Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / March 2026 / K252487

510(k) cleared

POWERSEAL Open Extended Jaw Sealer and Divider, Double-Action (PS-0021EJDA)

Gyrus Acmi, Inc. · Mar 2, 2026 · K252487

FDA cleared the POWERSEAL Open Extended Jaw Sealer and Divider, Double-Action (PS-0021EJDA) from Gyrus Acmi, Inc. on Mar 2, 2026 under K252487, a traditional 510(k). The device falls under product code GEI, Electrosurgical, Cutting & Coagulation & Accessories, regulated at 21 CFR 878.4400 as a Class 2 device. The review panel was General, Plastic Surgery.

FDA logged the submission as received on Aug 7, 2025. The decision came 207 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Gyrus Acmi, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252487?

K252487 is the FDA 510(k) for POWERSEAL Open Extended Jaw Sealer and Divider, Double-Action (PS-0021EJDA), submitted by Gyrus Acmi, Inc.. FDA's decision date was Mar 2, 2026, under product code GEI (Electrosurgical, Cutting & Coagulation & Accessories).

Who makes the POWERSEAL Open Extended Jaw Sealer and Divider, Double-Action (PS-0021EJDA)?

Gyrus Acmi, Inc., based in Westborough, MA, is the applicant of record for K252487.

How long did the K252487 review take?

FDA received the submission on Aug 7, 2025 and issued its decision on Mar 2, 2026, 207 days later.

← All decisions in March 2026