510(k) Report

Devices descending from K954311

13 later devices reach Koh Colpotomizer System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K143650CooperSurgical Advincula Delineator Uterine ManipulatorCooperSurgical, Inc.20152—
+1K131781Clearview TotalClinical Innovations, LLC201411
+1K111014Lsi Solutions Fornisee System Uterine Manipulator and AccessoriesLsi Solutions, Inc.20120—
+1K110819Singhmed Roolip ManipulatorJ.Singh Instruments20111—
+1K051160ManipusealInsitu Systems20050—
+1K051594Mccartney Access TubeGynetech Pty., Ltd.20053—
+2K172846Uterine ManipulatorBeijing Hangtian Kadi Technology R&D Institute20180—
+2K180429Advincula Delineator Uterine ManipulatorCooperSurgical, Inc.201812
+2K161065ColpoWave™ Colpotomizer and CerviGrip™ Uterine ManipulatorSurgitools Pty, Ltd.20160—
+2K143308GelPOINT Transvaginal Access PlatformApplied Medical Resources20152—
+3K201086Advincula Delineator Uterine ManipulatorCooperSurgical, Inc.20200—
+3K191294Transvaginal Access PlatformApplied Medical Resources Corp.20191—
+4K243152GelPOINT V-Path Transvaginal Access Platform with Retroperitoneal Access DeviceApplied Medical Resources Corp.20250—