K161905 - Disposable Circular Stapler for Hemorrhoids, Disposable Circular Stapler, Disposable Linear Stapler, Disposable Endoscopic Linear Cutter Stapler and Cartridge, Disposable Linear Cutter Stapler and Stapler Cartridge (FDA 510(k) Clearance)

K161905 is an FDA 510(k) clearance for the Disposable Circular Stapler for Hemorrhoids, Disposable Circular Stapler, Dis.... Classified as Staple, Implantable (product code GDW), Class II - Special Controls.

Submitted by Changzhou Xin Neng Yuan Medical Stapler Co.,Ltd (Changzhou, CN). The FDA issued a Cleared decision on November 17, 2016 after a review of 129 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4750 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Changzhou Xin Neng Yuan Medical Stapler Co.,Ltd devices