Name: Predicase
Price: 199 USD

K-number	K161905
Device name	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
Applicant	Changzhou Xin Neng Yuan Medical Stapler Co.,Ltd
Product code	GDW
Device class	Class II
Decision date	Nov 17, 2016
Decision	Substantially Equivalent
Regulation	878.4750

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Source

View the full FDA submission: accessdata.fda.gov

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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

Everything you need for a 510(k) submission. Nothing you don't.