510(k) Report

Devices descending from K160096

8 later devices reach InZone Detachment System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K212455InZone Detachment SystemStryker Neurovascular202111
+1K203625Numen Coil Embolization System; NumenFR Detachment SystemMicroPort NeuroTech (Shanghai) Co., Ltd.20213—
+1K192068i-ED COILKaneka Pharma America, LLC20201—
+2K251832InZone IST Detachment System; IZDS Connecting CableStryker Neurovascular20250—
+2K232955Numen Coil Embolization System; NumenFR Detachment SystemMicroPort NeuroTech (Shanghai) Co., Ltd.20242—
+2K210638i-ED COIL SystemKaneka Medical America, LLC20210—
+3K242154Numen™ Coil Embolization System; NumenFR™ Detachment SystemMicroPort NeuroTech (Shanghai) Co., Ltd.20241—
+4K260351Numen™ Helia Coil Embolization System; NumenFR™ Detachment SystemMicroPort NeuroTech (Shanghai) Co., Ltd.20260—