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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 / April 2026 / K253657

510(k) cleared

Tri-staple 2.0 Reloads; Endo GIA Reloads with Tri-Staple Technology; Endo GIA Gray Articulating Reloads; Signia Small Diameter Reloads

Covidien (Part of Medtronic) · Apr 10, 2026 · K253657

FDA cleared the Tri-staple 2.0 Reloads; Endo GIA Reloads with Tri-Staple Technology; Endo GIA Gray Articulating Reloads; Signia Small Diameter Reloads from Covidien (Part of Medtronic) on Apr 10, 2026 under K253657, a traditional 510(k). The device falls under product code GDW, Staple, Implantable, regulated at 21 CFR 878.4750 as a Class 2 device. The review panel was General, Plastic Surgery.

FDA logged the submission as received on Nov 20, 2025. The decision came 141 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 Covidien (Part of Medtronic) in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253657?

K253657 is the FDA 510(k) for Tri-staple 2.0 Reloads; Endo GIA Reloads with Tri-Staple Technology; Endo GIA Gray Articulating Reloads; Signia Small Diameter Reloads, submitted by Covidien (Part of Medtronic). FDA's decision date was Apr 10, 2026, under product code GDW (Staple, Implantable).

Who makes the Tri-staple 2.0 Reloads; Endo GIA Reloads with Tri-Staple Technology; Endo GIA Gray Articulating Reloads; Signia Small Diameter Reloads?

Covidien (Part of Medtronic), based in North Haven, CT, is the applicant of record for K253657.

How long did the K253657 review take?

FDA received the submission on Nov 20, 2025 and issued its decision on Apr 10, 2026, 141 days later.

← All decisions in April 2026