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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 / July 2026 / K254231

510(k) cleared

Inno-Hook Disposable Clip Appliers (Ligating Clips) and Inno-Hook Ligating Clips

Taiwan Surgical Corporation · Jul 20, 2026 · K254231

FDA cleared the Inno-Hook Disposable Clip Appliers (Ligating Clips) and Inno-Hook Ligating Clips from Taiwan Surgical Corporation on Jul 20, 2026 under K254231, a traditional 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 29, 2025. The decision came 203 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Taiwan Surgical Corporation has 3 other decisions in the tracker over the last 12 months: K252532 (Inno-Port Disposable Bladed Trocar), K253781 (InnoClip Clip Applier), K253903 (InnoClip Disposable Clip Applier).

Questions & Answers

What did FDA clear under K254231?

K254231 is the FDA 510(k) for Inno-Hook Disposable Clip Appliers (Ligating Clips) and Inno-Hook Ligating Clips, submitted by Taiwan Surgical Corporation. FDA's decision date was Jul 20, 2026, under product code FZP (Clip, Implantable).

Who makes the Inno-Hook Disposable Clip Appliers (Ligating Clips) and Inno-Hook Ligating Clips?

Taiwan Surgical Corporation, based in Zhubei City, is the applicant of record for K254231.

How long did the K254231 review take?

FDA received the submission on Dec 29, 2025 and issued its decision on Jul 20, 2026, 203 days later.

← All decisions in July 2026

Sources