510(k) K254231

Inno-Hook™ Disposable Clip Appliers (Ligating Clips) and Inno-Hook™ Ligating Clips by Taiwan Surgical Corporation — Product Code FZP

K254231 is an FDA 510(k) premarket notification submitted by Taiwan Surgical Corporation for the device "Inno-Hook™ Disposable Clip Appliers (Ligating Clips) and Inno-Hook™ Ligating Clips". The FDA issued a decision of Substantially Equivalent on July 20, 2026. The device falls under product code FZP (Clip, Implantable), a Class II device regulated under 21 CFR 878.4300. Taiwan Surgical Corporation has at least 7 other 510(k) clearances on record.