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 / October 2025 / K252572

510(k) cleared

Prodeon Urethral Sheath System

Prodeon Medical, Inc. · Oct 7, 2025 · K252572

FDA cleared the Prodeon Urethral Sheath System from Prodeon Medical, Inc. on Oct 7, 2025 under K252572, a traditional 510(k). The device falls under product code FED, Endoscopic Access Overtube, Gastroenterology-Urology, regulated at 21 CFR 876.1500 as a Class 2 device. The review panel was Gastroenterology, Urology.

FDA logged the submission as received on Aug 14, 2025. The decision came 54 days later, inside the 90 FDA-day goal for a 510(k).

Prodeon Medical, Inc. has 2 other decisions in the tracker over the last 12 months: K261342 (Urocross Expander System (UES-2018-C1)), K253525 (Urocross Expander System (Model Numbers ES2018 and ES3025)).

Questions & Answers

What did FDA clear under K252572?

K252572 is the FDA 510(k) for Prodeon Urethral Sheath System, submitted by Prodeon Medical, Inc.. FDA's decision date was Oct 7, 2025, under product code FED (Endoscopic Access Overtube, Gastroenterology-Urology).

Who makes the Prodeon Urethral Sheath System?

Prodeon Medical, Inc., based in Sunnyvale, CA, is the applicant of record for K252572.

How long did the K252572 review take?

FDA received the submission on Aug 14, 2025 and issued its decision on Oct 7, 2025, 54 days later.

← All decisions in October 2025

Sources