510(k) Report

Devices descending from K060899

19 later devices reach Flexilux II Cystoscope and Hysteroscope through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K150158Schoelly Cystoscopes/Hysteroscopes and AccessoriesSchoelly Fiberoptic GmbH2015181
+2K251652Strauss Surgical Cystoscopes & Hysteroscopes (STS-2040-302ASA HD-endoscope…American Medical Endoscopy, Inc.20251—
+2K201970Schoelly Cystoscopes/Hysteroscopes and AccessoriesSchoelly Fiberoptic GmbH20200—
+2K170862Vesair 0 degree Cystoscope, Vesair 30 degree Long Cystoscope, Vesair 70 degree Long…Solace Therapeutics, Inc.20170—
+2K170660Endosee Hysteroscope with Disposable Diagnostic (Dx) CannulaCooperSurgical, Inc.20175—
+2K161110ClearPetra Suction-Evacuation SheathWell Lead Medical Co., Ltd.20167—
+3K261915Navigator™ Flex Ureteral Access Sheath SetBoston Scientific Corporation20260—
+3K253892Strauss Surgical Cystoscopes & Hysteroscopes (STS-2040-302ASA HD-endoscope, 4 x 302 mm…Strauss Surgical USA20260—
+3K250128Single Use Suction-Evacuation Ureteral Access SheathAnhui Happiness Workshop Medical Instruments Co., Ltd.20250—
+3K243820Hoover Negative Pressure Access Sheath (Hoover) (Hoover Model #'s IVX-NS-1040…Dornier Medtech America20251—
+3K243025Ureteral Access SheathSeplou (Zhuhai) Co., Ltd.20250—
+3K203119ClearPetra Suction-Evacuation SheathWell Lead Medical Co., Ltd.20200—
+3K200419Kalera Vacuum Aspiration Catheter (K-VAC)Kalera Medical, Inc.20200—
+3K183020Endosee SystemCooperSurgical, Inc.201941
+4K252572Prodeon Urethral Sheath SystemProdeon Medical, Inc.20250—
+4K190639Endosee SystemCooperSurgical, Inc.201931
+5K200038Endosee SystemCooperSurgical, Inc.20201—
+5K193007LiNA OperaScope with HDMI cable and on-board LCD - 6 units, LiNA OperaScope Recording…Lina Medical Aps20200—
+6K254251InnovexView (GC146-17, GC150-20, GC155-23)Shanghai AnQing Medical Instrument Co., Ltd.20260—