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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 / December 2025 / K253903

510(k) cleared

InnoClip Disposable Clip Applier

Taiwan Surgical Corporation · Dec 22, 2025 · K253903

FDA cleared the InnoClip Disposable Clip Applier from Taiwan Surgical Corporation on Dec 22, 2025 under K253903, a special 510(k). The device falls under product code FZP, Clip, Implantable, regulated at 21 CFR 878.4300 as a Class 2 device. The review panel was General, Plastic Surgery.

FDA logged the submission as received on Dec 5, 2025. The decision came 17 days later, inside the 90 FDA-day goal for a 510(k).

Taiwan Surgical Corporation has 3 other decisions in the tracker over the last 12 months: K254231 (Inno-Hook Disposable Clip Appliers (Ligating Clips) and Inno-Hook Ligating Clips), K252532 (Inno-Port Disposable Bladed Trocar), K253781 (InnoClip Clip Applier).

Questions & Answers

What did FDA clear under K253903?

K253903 is the FDA 510(k) for InnoClip Disposable Clip Applier, submitted by Taiwan Surgical Corporation. FDA's decision date was Dec 22, 2025, under product code FZP (Clip, Implantable).

Who makes the InnoClip Disposable Clip Applier?

Taiwan Surgical Corporation, based in Zhubei City, is the applicant of record for K253903.

How long did the K253903 review take?

FDA received the submission on Dec 5, 2025 and issued its decision on Dec 22, 2025, 17 days later.

← All decisions in December 2025

Sources