510(k) Report

Devices descending from K770729

12 later devices reach Pyeloscope System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K994223Nephroscope, 12 Degrees; Diaphragm Valve; Irrigation Attachment; Nephroscope, 20 Degree…Richard Wolf Medical Instruments Corp.200011—
+2K213334Monarch Platform, UrologyAuris Health, Inc.202201
+2K200770Mini PCNL-SystemTrokamed GmbH20210Class I
+2K151308Schoelly Nephroscope Set, Schoelly Ultra-Mini Nephroscope SetSchoelly Fiberoptic GmbH20168—
+3K161110ClearPetra Suction-Evacuation SheathWell Lead Medical Co., Ltd.20167—
+4K261915Navigator™ Flex Ureteral Access Sheath SetBoston Scientific Corporation20260—
+4K250128Single Use Suction-Evacuation Ureteral Access SheathAnhui Happiness Workshop Medical Instruments Co., Ltd.20250—
+4K243820Hoover Negative Pressure Access Sheath (Hoover) (Hoover Model #'s IVX-NS-1040…Dornier Medtech America20251—
+4K243025Ureteral Access SheathSeplou (Zhuhai) Co., Ltd.20250—
+4K203119ClearPetra Suction-Evacuation SheathWell Lead Medical Co., Ltd.20200—
+4K200419Kalera Vacuum Aspiration Catheter (K-VAC)Kalera Medical, Inc.20200—
+5K252572Prodeon Urethral Sheath SystemProdeon Medical, Inc.20250—