Name: Predicase
Price: 199 USD

K-number	K201639
Device name	Disposable Circular Staple, Disposable Hemorrhoidal Stapler, Disposable Linear Stapler and Reloads, Disposable Linear Cutter Stapler and Reloads, Disposable Endoscopic Linear Cutter Stapler and Reloads
Applicant	Beijing Biosis Healing Biolog Ical Technology Co., Ltd.
Product code	GDW
Device class	Class II
Decision date	May 27, 2021
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 Staple, Disposable Hemorrhoidal Stapler, Disposable Linear Stapler and Reloads, Disposable Linear Cutter Stapler and Reloads, Disposable Endoscopic Linear Cutter Stapler and Reloads

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