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The Tracker / August 2026 / K252535

510(k) cleared

Inno-Switch Laparoscopic Instruments

Taiwan Surgical Corporation · Aug 25, 2026 · K252535

FDA cleared the Inno-Switch Laparoscopic Instruments from Taiwan Surgical Corporation on Aug 25, 2026 under K252535, a traditional 510(k). The device falls under product code GEI, Electrosurgical, Cutting & Coagulation & Accessories, regulated at 21 CFR 878.4400 as a Class 2 device. The review panel was General, Plastic Surgery.

FDA logged the submission as received on Aug 12, 2025. The decision came 378 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Taiwan Surgical Corporation has 4 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), K253903 (InnoClip Disposable Clip Applier).

Questions & Answers

What did FDA clear under K252535?

K252535 is the FDA 510(k) for Inno-Switch Laparoscopic Instruments, submitted by Taiwan Surgical Corporation. FDA's decision date was Aug 25, 2026, under product code GEI (Electrosurgical, Cutting & Coagulation & Accessories).

Who makes the Inno-Switch Laparoscopic Instruments?

Taiwan Surgical Corporation, based in Zhubei City, is the applicant of record for K252535.

How long did the K252535 review take?

FDA received the submission on Aug 12, 2025 and issued its decision on Aug 25, 2026, 378 days later.

← All decisions in August 2026

Sources