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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 / K253781

510(k) cleared

InnoClip Clip Applier

Taiwan Surgical Corporation · Dec 22, 2025 · K253781

FDA cleared the InnoClip Clip Applier from Taiwan Surgical Corporation on Dec 22, 2025 under K253781, 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 Nov 26, 2025. The decision came 26 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), K253903 (InnoClip Disposable Clip Applier).

Questions & Answers

What did FDA clear under K253781?

K253781 is the FDA 510(k) for InnoClip 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 Clip Applier?

Taiwan Surgical Corporation, based in Zhubei City, is the applicant of record for K253781.

How long did the K253781 review take?

FDA received the submission on Nov 26, 2025 and issued its decision on Dec 22, 2025, 26 days later.

← All decisions in December 2025

Sources