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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 / June 2026 / K260394

510(k) cleared

Hydrophilic coated intermittent nalaton catheter for single use-ready to use (NCR)

Hangzhou Jimushi Meditech Co., Ltd. · Jun 24, 2026 · K260394

FDA cleared the Hydrophilic coated intermittent nalaton catheter for single use-ready to use (NCR) from Hangzhou Jimushi Meditech Co., Ltd. on Jun 24, 2026 under K260394, a traditional 510(k). The device falls under product code EZD, Catheter, Straight, regulated at 21 CFR 876.5130 as a Class 2 device. The review panel was Gastroenterology, Urology.

FDA logged the submission as received on Feb 6, 2026. The decision came 138 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 Hangzhou Jimushi Meditech Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260394?

K260394 is the FDA 510(k) for Hydrophilic coated intermittent nalaton catheter for single use-ready to use (NCR), submitted by Hangzhou Jimushi Meditech Co., Ltd.. FDA's decision date was Jun 24, 2026, under product code EZD (Catheter, Straight).

Who makes the Hydrophilic coated intermittent nalaton catheter for single use-ready to use (NCR)?

Hangzhou Jimushi Meditech Co., Ltd., based in Hangzhou, is the applicant of record for K260394.

How long did the K260394 review take?

FDA received the submission on Feb 6, 2026 and issued its decision on Jun 24, 2026, 138 days later.

← All decisions in June 2026