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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 / K252532

510(k) cleared

Inno-Port Disposable Bladed Trocar

Taiwan Surgical Corporation · Jun 2, 2026 · K252532

FDA cleared the Inno-Port Disposable Bladed Trocar from Taiwan Surgical Corporation on Jun 2, 2026 under K252532, a traditional 510(k). The device falls under product code GCJ, Laparoscope, General & Plastic Surgery, regulated at 21 CFR 876.1500 as a Class 2 device. The review panel was Gastroenterology, Urology.

FDA logged the submission as received on Aug 12, 2025. The decision came 294 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: K254231 (Inno-Hook Disposable Clip Appliers (Ligating Clips) and Inno-Hook Ligating Clips), K253781 (InnoClip Clip Applier), K253903 (InnoClip Disposable Clip Applier).

Questions & Answers

What did FDA clear under K252532?

K252532 is the FDA 510(k) for Inno-Port Disposable Bladed Trocar, submitted by Taiwan Surgical Corporation. FDA's decision date was Jun 2, 2026, under product code GCJ (Laparoscope, General & Plastic Surgery).

Who makes the Inno-Port Disposable Bladed Trocar?

Taiwan Surgical Corporation, based in Zhubei City, is the applicant of record for K252532.

How long did the K252532 review take?

FDA received the submission on Aug 12, 2025 and issued its decision on Jun 2, 2026, 294 days later.

← All decisions in June 2026

Sources