510(k) Report

Devices descending from K001895

22 later devices reach Auto Suture Premium Plus Ceea Disposable Stapler through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K090821Chex Single Use Curved Intraluminal Circular Stapler, Model CS 21, CS 25, CS 28, CS 32…Frankenman International Limited200921—
+2K120179Reach Surgical StaplersReach Surgical, Inc.201217—
+2K101378Frankenman Surgical StaplersSuzhou Frankenman Medical Equipment Co., Ltd.20101—
+2K100386Disposable Circular Stapler, Models Why-25, Why-29. Why 32Changzhou Waston Medical Appliance Co., Ltd.20100—
+3K211811Disposable Endoscopic Staplers and Reload Unit, Disposable Hemorrhoidal Cutter Staplers…Wuxi Beien Surgery Device Co., Ltd.20220—
+3K192566Reach and CQ'ENCE Circular StaplersReach Surgical, Inc.20190—
+3K161905Disposable Circular Stapler for Hemorrhoids, Disposable Circular Stapler, Disposable…Changzhou Xin Neng Yuan Medical Stapler Co.,Ltd20160—
+3K141367LS Series Linear Stapler and Reloads, CLC Series Curved Linear Cutter and Reloads, LC…Touchstone International Medical Science Co., Ltd.20147—
+3K133499Suzhou Beinuo Surgical Staplers - Circular Staplers for Single Use, Hemorrhoidal…Suzhou Beinuo Medical Equipment Co., Ltd.20140—
+3K130738Endoscopic Linear Cutting Staplers with Single Use Loading UnitsNanjing Maidixin Medical Device Co., Ltd.20130—
+3K131511Disposable Circular Stapler, Disposable Curved Cutter Stapler, Disposable Linear…Changzhou Sinolinks Medical Innovation Co., Ltd.201314—
+4K173443AEON Endoscopic StaplerLexington Medical, Inc.20185—
+4K171589AEON Endoscopic StaplerLexington Medical, Inc.20170—
+4K161757Single Use Curved Cutters, Single Use Circular Staplers, Single Use Linear Cutters and…Victor Medical Instruments Co., Ltd.20163—
+4K141097CSC Series Intraluminal Stapler for Single UseTouchstone International Medical Science Co., Ltd.20140—
+5K211197Disposable Endoscopic Cutter Stapler and CartridgeChangzhou Waston Medical Appliance Co., Ltd.20230—
+5K211458Disposable Anorectal Staplers, Disposable Intraluminal Staplers, Disposable Linear…Ningbo Verykind Medical Device Co., Ltd.20210—
+5K182380AEON Endoscopic StaplerLexington Medical, Inc.20184—
+6K201882AEON Endoscopic StaplerLexington Medical, Inc.20203—
+7K222210AEON Endoscopic StaplerLexington Medical, Inc.20232—
+8K251482AEON™ Endoscopic Powered StaplerLexington Medical, Inc.20250—
+8K234039AEON Endoscopic Powered Stapler (Short/AEPH060); AEON Endoscopic Powered Stapler…Lexington Medical, Inc.20240—