510(k) Report

Devices descending from K120816

9 later devices reach Inzone Detachment System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K160096InZone Detachment SystemStryker Neurovascular20168—
+2K212455InZone Detachment SystemStryker Neurovascular202111
+2K203625Numen Coil Embolization System; NumenFR Detachment SystemMicroPort NeuroTech (Shanghai) Co., Ltd.20213—
+2K192068i-ED COILKaneka Pharma America, LLC20201—
+3K251832InZone IST Detachment System; IZDS Connecting CableStryker Neurovascular20250—
+3K232955Numen Coil Embolization System; NumenFR Detachment SystemMicroPort NeuroTech (Shanghai) Co., Ltd.20242—
+3K210638i-ED COIL SystemKaneka Medical America, LLC20210—
+4K242154Numen™ Coil Embolization System; NumenFR™ Detachment SystemMicroPort NeuroTech (Shanghai) Co., Ltd.20241—
+5K260351Numen™ Helia Coil Embolization System; NumenFR™ Detachment SystemMicroPort NeuroTech (Shanghai) Co., Ltd.20260—