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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 / May 2026 / K252617

510(k) cleared

MiroCam® Capsule Endoscope System

Intromedic Co., Ltd. · May 8, 2026 · K252617

FDA cleared the MiroCam® Capsule Endoscope System from Intromedic Co., Ltd. on May 8, 2026 under K252617, a special 510(k). The device falls under product code NEZ, System, Imaging, Gastrointestinal, Wireless, Capsule, regulated at 21 CFR 876.1300 as a Class 2 device. The review panel was Gastroenterology, Urology.

FDA logged the submission as received on Aug 19, 2025. The decision came 262 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 Intromedic Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252617?

K252617 is the FDA 510(k) for MiroCam® Capsule Endoscope System, submitted by Intromedic Co., Ltd.. FDA's decision date was May 8, 2026, under product code NEZ (System, Imaging, Gastrointestinal, Wireless, Capsule).

Who makes the MiroCam® Capsule Endoscope System?

Intromedic Co., Ltd., based in Guro-Dong, Guro-Gu, is the applicant of record for K252617.

How long did the K252617 review take?

FDA received the submission on Aug 19, 2025 and issued its decision on May 8, 2026, 262 days later.

← All decisions in May 2026