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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 / August 2026 / K253505

510(k) cleared

Zamenix P

Roen Surgical, Inc. · Aug 7, 2026 · K253505

FDA cleared the Zamenix P from Roen Surgical, Inc. on Aug 7, 2026 under K253505, a traditional 510(k). The device falls under product code FGB, Ureteroscope 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 Oct 31, 2025. The decision came 280 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 Roen Surgical, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253505?

K253505 is the FDA 510(k) for Zamenix P, submitted by Roen Surgical, Inc.. FDA's decision date was Aug 7, 2026, under product code FGB (Ureteroscope And Accessories, Flexible/Rigid).

Who makes the Zamenix P?

Roen Surgical, Inc., based in Daejeon, is the applicant of record for K253505.

How long did the K253505 review take?

FDA received the submission on Oct 31, 2025 and issued its decision on Aug 7, 2026, 280 days later.

← All decisions in August 2026