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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 / July 2026 / K253527

510(k) cleared

Tri-Staple 2.0 Black Circular Reload 21mm Extra Thick (SIGCIR21XT); Tri-Staple 2.0 Black Circular Reload 25mm Extra Thick (SIGCIR25XT)

Covidien, LLC · Jul 1, 2026 · K253527

FDA cleared the Tri-Staple 2.0 Black Circular Reload 21mm Extra Thick (SIGCIR21XT); Tri-Staple 2.0 Black Circular Reload 25mm Extra Thick (SIGCIR25XT) from Covidien, LLC on Jul 1, 2026 under K253527, a traditional 510(k). The device falls under product code GAG, Stapler, Surgical, regulated at 21 CFR 878.4740 as a Class 2 device. The review panel was General Hospital.

FDA logged the submission as received on Nov 13, 2025. The decision came 230 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Covidien, LLC has 8 other decisions in the tracker over the last 12 months: K260907 (BIS Advance pEEG Module), K253984 (Instrument Exit Point on Touch Surgery Aide), K253030 (Capnostream35 Portable Respiratory Monitor (PM35MN)), K251025 (Mon-a-Therm Esophageal Stethoscope with Temperature Sensor 400TM (90041, 90042, 90043, 90049)).

Questions & Answers

What did FDA clear under K253527?

K253527 is the FDA 510(k) for Tri-Staple 2.0 Black Circular Reload 21mm Extra Thick (SIGCIR21XT); Tri-Staple 2.0 Black Circular Reload 25mm Extra Thick (SIGCIR25XT), submitted by Covidien, LLC. FDA's decision date was Jul 1, 2026, under product code GAG (Stapler, Surgical).

Who makes the Tri-Staple 2.0 Black Circular Reload 21mm Extra Thick (SIGCIR21XT); Tri-Staple 2.0 Black Circular Reload 25mm Extra Thick (SIGCIR25XT)?

Covidien, LLC, based in North Haven, CT, is the applicant of record for K253527.

How long did the K253527 review take?

FDA received the submission on Nov 13, 2025 and issued its decision on Jul 1, 2026, 230 days later.

← All decisions in July 2026