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 / July 2026 / K262006

510(k) cleared

EnSite X EP System

Abbott Medical · Jul 15, 2026 · K262006

FDA cleared the EnSite X EP System from Abbott Medical on Jul 15, 2026 under K262006, a special 510(k). The device falls under product code DQK, Computer, Diagnostic, Programmable, regulated at 21 CFR 870.1425 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Jun 15, 2026. The decision came 30 days later, inside the 90 FDA-day goal for a 510(k).

Abbott Medical has 8 other decisions in the tracker over the last 12 months: K261825 (Amplatzer TorqVue LP Delivery System; Amplatzer TorqVue LP Catheter), K261631 (Amplatzer TorqVue Exchange System), K253459 (OPTIS Mobile Next Imaging System (1014932); OPTIS Integrated Next Imaging System (1014933); Ultreon 3.0 Software Upgrade Kit (ULTR300001)), K260993 (Amplatzer TorqVue Delivery System).

Questions & Answers

What did FDA clear under K262006?

K262006 is the FDA 510(k) for EnSite X EP System, submitted by Abbott Medical. FDA's decision date was Jul 15, 2026, under product code DQK (Computer, Diagnostic, Programmable).

Who makes the EnSite X EP System?

Abbott Medical, based in St. Paul, MN, is the applicant of record for K262006.

How long did the K262006 review take?

FDA received the submission on Jun 15, 2026 and issued its decision on Jul 15, 2026, 30 days later.

← All decisions in July 2026