510(k) Report

Devices descending from K992983

22 later devices reach Baho Autoclavable Cystoscope through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K031141Asap Cystoscope; Asap Laparoscope; Asap Larygoscope; Asap OesophagoscopeAsap Endoscopic Products GmbH200321—
+2K093725Cystoscope, Models CE0004-C, CE006-C, CE3004-C, CE3027-C, CE7004-C, CE1204-C, CE1227-CCanada Endoscope Corporation20100—
+2K060899Flexilux II Cystoscope and HysteroscopeSchoelly Imaging, Inc.200719—
+3K150158Schoelly Cystoscopes/Hysteroscopes and AccessoriesSchoelly Fiberoptic GmbH2015181
+4K251652Strauss Surgical Cystoscopes & Hysteroscopes (STS-2040-302ASA HD-endoscope…American Medical Endoscopy, Inc.20251—
+4K201970Schoelly Cystoscopes/Hysteroscopes and AccessoriesSchoelly Fiberoptic GmbH20200—
+4K170862Vesair 0 degree Cystoscope, Vesair 30 degree Long Cystoscope, Vesair 70 degree Long…Solace Therapeutics, Inc.20170—
+4K170660Endosee Hysteroscope with Disposable Diagnostic (Dx) CannulaCooperSurgical, Inc.20175—
+4K161110ClearPetra Suction-Evacuation SheathWell Lead Medical Co., Ltd.20167—
+5K261915Navigator™ Flex Ureteral Access Sheath SetBoston Scientific Corporation20260—
+5K253892Strauss Surgical Cystoscopes & Hysteroscopes (STS-2040-302ASA HD-endoscope, 4 x 302 mm…Strauss Surgical USA20260—
+5K250128Single Use Suction-Evacuation Ureteral Access SheathAnhui Happiness Workshop Medical Instruments Co., Ltd.20250—
+5K243820Hoover Negative Pressure Access Sheath (Hoover) (Hoover Model #'s IVX-NS-1040…Dornier Medtech America20251—
+5K243025Ureteral Access SheathSeplou (Zhuhai) Co., Ltd.20250—
+5K203119ClearPetra Suction-Evacuation SheathWell Lead Medical Co., Ltd.20200—
+5K200419Kalera Vacuum Aspiration Catheter (K-VAC)Kalera Medical, Inc.20200—
+5K183020Endosee SystemCooperSurgical, Inc.201941
+6K252572Prodeon Urethral Sheath SystemProdeon Medical, Inc.20250—
+6K190639Endosee SystemCooperSurgical, Inc.201931
+7K200038Endosee SystemCooperSurgical, Inc.20201—
+7K193007LiNA OperaScope with HDMI cable and on-board LCD - 6 units, LiNA OperaScope Recording…Lina Medical Aps20200—
+8K254251InnovexView (GC146-17, GC150-20, GC155-23)Shanghai AnQing Medical Instrument Co., Ltd.20260—