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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 / December 2025 / K252021

510(k) cleared

Disposable Endoscopic Injection Needles

Changzhou New Med Micro-Medtech Co., Ltd. · Dec 2, 2025 · K252021

FDA cleared the Disposable Endoscopic Injection Needles from Changzhou New Med Micro-Medtech Co., Ltd. on Dec 2, 2025 under K252021, a traditional 510(k). The device falls under product code FBK, Endoscopic Injection Needle, 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 Jun 30, 2025. The decision came 155 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 Changzhou New Med Micro-Medtech Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252021?

K252021 is the FDA 510(k) for Disposable Endoscopic Injection Needles, submitted by Changzhou New Med Micro-Medtech Co., Ltd.. FDA's decision date was Dec 2, 2025, under product code FBK (Endoscopic Injection Needle, Gastroenterology-Urology).

Who makes the Disposable Endoscopic Injection Needles?

Changzhou New Med Micro-Medtech Co., Ltd., based in Changzhou, is the applicant of record for K252021.

How long did the K252021 review take?

FDA received the submission on Jun 30, 2025 and issued its decision on Dec 2, 2025, 155 days later.

← All decisions in December 2025