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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 / October 2025 / K251708

510(k) cleared

EvoEndo Single-Use Endoscopy System

EvoEndo, Inc. · Oct 10, 2025 · K251708

FDA cleared the EvoEndo Single-Use Endoscopy System from EvoEndo, Inc. on Oct 10, 2025 under K251708, a traditional 510(k). The device falls under product code FDS, Gastroscope And Accessories, Flexible/Rigid, regulated at 21 CFR 876.1500 as a Class 2 device. The review panel was Gastroenterology, Urology.

FDA logged the submission as received on Jun 3, 2025. The decision came 129 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

EvoEndo, Inc. has one other decision in the tracker over the last 12 months: K260573 (EvoEndo Single-Use Endoscopy System).

Questions & Answers

What did FDA clear under K251708?

K251708 is the FDA 510(k) for EvoEndo Single-Use Endoscopy System, submitted by EvoEndo, Inc.. FDA's decision date was Oct 10, 2025, under product code FDS (Gastroscope And Accessories, Flexible/Rigid).

Who makes the EvoEndo Single-Use Endoscopy System?

EvoEndo, Inc., based in Grayslake, IL, is the applicant of record for K251708.

How long did the K251708 review take?

FDA received the submission on Jun 3, 2025 and issued its decision on Oct 10, 2025, 129 days later.

← All decisions in October 2025

Sources