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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 / June 2026 / K260636

510(k) cleared

Remanufactured LigaSure XP Maryland Jaw Sealer/Divider Without Nano-coating

Stryker Sustainability Solutions · Jun 18, 2026 · K260636

FDA cleared the Remanufactured LigaSure XP Maryland Jaw Sealer/Divider Without Nano-coating from Stryker Sustainability Solutions on Jun 18, 2026 under K260636, 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 Feb 26, 2026. The decision came 112 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 Stryker Sustainability Solutions in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260636?

K260636 is the FDA 510(k) for Remanufactured LigaSure XP Maryland Jaw Sealer/Divider Without Nano-coating, submitted by Stryker Sustainability Solutions. FDA's decision date was Jun 18, 2026, under product code GEI (Electrosurgical, Cutting & Coagulation & Accessories).

Who makes the Remanufactured LigaSure XP Maryland Jaw Sealer/Divider Without Nano-coating?

Stryker Sustainability Solutions, based in Tempe, AZ, is the applicant of record for K260636.

How long did the K260636 review take?

FDA received the submission on Feb 26, 2026 and issued its decision on Jun 18, 2026, 112 days later.

← All decisions in June 2026