510(k) Report

Devices descending from K994223

11 later devices reach Nephroscope, 12 Degrees; Diaphragm Valve; Irrigation Attachment; Nephroscope… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K213334Monarch Platform, UrologyAuris Health, Inc.202201
+1K200770Mini PCNL-SystemTrokamed GmbH20210Class I
+1K151308Schoelly Nephroscope Set, Schoelly Ultra-Mini Nephroscope SetSchoelly Fiberoptic GmbH20168—
+2K161110ClearPetra Suction-Evacuation SheathWell Lead Medical Co., Ltd.20167—
+3K261915Navigator™ Flex Ureteral Access Sheath SetBoston Scientific Corporation20260—
+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—
+4K252572Prodeon Urethral Sheath SystemProdeon Medical, Inc.20250—