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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 / June 2026 / K253984

510(k) cleared

Instrument Exit Point on Touch Surgery Aide

Covidien, LLC · Jun 4, 2026 · K253984

FDA cleared the Instrument Exit Point on Touch Surgery Aide from Covidien, LLC on Jun 4, 2026 under K253984, a traditional 510(k). The device falls under product code SFE, Endoscopic Video Imaging System / Software Component For Real Time Video Augmentation, regulated at 21 CFR 876.1500 as a Class 2 device. The review panel was Gastroenterology, Urology.

FDA logged the submission as received on Dec 12, 2025. The decision came 174 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), K253527 (Tri-Staple 2.0 Black Circular Reload 21mm Extra Thick (SIGCIR21XT); Tri-Staple 2.0 Black Circular Reload 25mm Extra Thick (SIGCIR25XT)), 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 K253984?

K253984 is the FDA 510(k) for Instrument Exit Point on Touch Surgery Aide, submitted by Covidien, LLC. FDA's decision date was Jun 4, 2026, under product code SFE (Endoscopic Video Imaging System / Software Component For Real Time Video Augmentation).

Who makes the Instrument Exit Point on Touch Surgery Aide?

Covidien, LLC, based in Mansfield, MA, is the applicant of record for K253984.

How long did the K253984 review take?

FDA received the submission on Dec 12, 2025 and issued its decision on Jun 4, 2026, 174 days later.

← All decisions in June 2026