ClearanceBrief
Panels › Neurology › Product code HCG · Class 2

Device, Neurovascular Embolization

Regulation 882.5950

5510(k)s in 12 months (187 all time)
2recalls in 12 months (68 all time)
67recalls that name a 510(k)
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Top companies in HCG

Company510(k)sRecalls
MicroVention, Inc.3216
Stryker Neurovascular1137
Cordis Neurovascular130
Boston Scientific, Target111
Micro Therapeutics, Inc.111
Boston Scientific Corp110
Micrus Endovascular Corporation110
Penumbra, Inc.101
Balt USA, LLC55
Target Therapeutics90
Decided510(k)Device and applicantCode
Aug 14, 2026K262419MICRUSFRAME (MFR100202); MICRUSFRAME (MFR100253); MICRUSFRAME (MFR100305); MICRUSFRAME (MFR100356); MICRUSFRAME (MFR1004
Cerenovus, Inc.
HCG
Jun 24, 2026K261772Target Xtra Detachable Coil
Stryker Neurovscular
HCG
May 20, 2026K260351Numen™ Helia Coil Embolization System; NumenFR™ Detachment System
MicroPort NeuroTech (Shanghai) Co., Ltd., CN
HCG
Jan 27, 2026K254221Optima Coil System (OptiOne Coil System)
Balt USA, LLC
HCG
Dec 11, 2025K252694Target Detachable Coil
Stryker Neurovascular
HCG
Oct 17, 2025K251832InZone IST Detachment System; IZDS Connecting Cable
Stryker Neurovascular
HCG
Sep 26, 2025K252700Optima Coil System (Optima Packing Coil System)
Balt USA, LLC
HCG
Sep 30, 2024K242154Numen™ Coil Embolization System; NumenFR™ Detachment System
MicroPort NeuroTech (Shanghai) Co., Ltd., CN
HCG
Sep 27, 2024K242582Optima Coil System (OptiBlock Line Extension)
Balt USA, LLC
HCG
Aug 29, 2024K242243Target Detachable Coils
Stryker Neurovscular
HCG
Jan 10, 2024K232955Numen Coil Embolization System; NumenFR Detachment System
MicroPort NeuroTech (Shanghai) Co., Ltd., CN
HCG
Nov 7, 2023K233420Axium Detachable Coil; Axium Prime Detachable Coil
Micro Therapeutics Lnc. D/B/A Ev3 Neurovascular
HCG
Oct 25, 2023K230284Penumbra LP Coil System
Penumbra, Inc.
HCG
Dec 14, 2022K222533Target Tetra Detachable Coils
Stryker Neurovascular
HCG
Dec 6, 2022K223386Optima Coil System
Balt USA, LLC
HCG
Jul 14, 2022K220040CEREPAK Uniform, Uniform XL, Uniform 3D, Heliform Soft, Heliform XtraSoft, Heliform XL, Heliform XtraSoft XL, Freeform,
Medos International SARL, CH
HCG
Nov 16, 2021K212455InZone Detachment System
Stryker Neurovascular
HCG
Sep 1, 2021K203625Numen Coil Embolization System; NumenFR Detachment System
MicroPort NeuroTech (Shanghai) Co., Ltd., CN
HCG
Jul 7, 2021K203432Axium Detachable Coil; Axium Prime Detachable Coil
Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
HCG
May 28, 2021K211344MICRUSFRAME, DELTAFILL, DELTAXSFT, GALAXY G3, GALAXY G3 XSFT, and GALAXY G3 Mini Microcoil Delivery Systems
Medos International SARL, CH
HCG
Mar 26, 2021K210638i-ED COIL System
Kaneka Medical America, LLC
HCG
Apr 25, 2020K192068i-ED COIL
Kaneka Pharma America, LLC
HCG
Feb 1, 2020K200030Optima Coil System
Balt USA, LLC
HCG
Nov 20, 2019K192955Penumbra LP Coil System
Penumbra, Inc.
HCG
Dec 4, 2018K180653Spartan eCoil System
Spartan Micro, Inc.
HCG
May 4, 2018K173711Wallaby Avenir Coil System
Wallaby Medical, Inc.
HCG
Apr 17, 2018K173614Penumbra Coil 400, Ruby Coil System, POD System
Penumbra, Inc.
HCG
Feb 18, 2018K172390Optima Coil System
Blockade Medical, LLC (D.B.A. Balt Usa)
HCG
Sep 25, 2017K171862GALAXY G3 Mini Microcoil Delivery System
Codman & Shurtleff, Inc.
HCG
Jul 19, 2017K170852POD Packing Coil
Penumbra, Inc.
HCG
Jul 14, 2017K171747MICRUSFRAME 10 Stretch Resistant Microcoil Delivery System, MICRUSFRAME 18 Stretch Resistant Microcoil Delivery System,
Codman & Shurtleff, Inc.
HCG
Mar 29, 2017K162999V-Grip Detachment Controller for use with Hydrocoil Embolic System and MicroPlex Coil System, AZUR Detachment Controller
MicroVention, Inc.
HCG
Jan 3, 2017K162704Axium Prime Detachable Coil System
Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
HCG
Aug 31, 2016K161452MicroPlex Coil System (MCS) - HyperSoft 3D
MicroVention, Inc.
HCG
Aug 31, 2016K161367HydroCoil Embolic System (HES)
MicroVention, Inc.
HCG
Jun 22, 2016K161429Target Detachable Coils
Stryker Neurovascular
HCG
May 19, 2016K153658Target Detachable Coils
Stryker Neurovascular
HCG
Apr 20, 2016K160832Penumbra Smart Coil
Penumbra, Inc.
HCG
Feb 19, 2016K160096InZone Detachment System
Stryker Neurovascular
HCG
Jan 22, 2016K153594MicroPlex Coil System (MCS), Hydrocoil Embolic System (HES)
MicroVention, Inc.
HCG
Jul 28, 2015K151447Axium Detachable Coil System
Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
HCG
Jul 27, 2015K151760Barricade Embolization Coil System
Blockade Medical
HCG
Jul 10, 2015K151572Penumbra Smart Coil
Penumbra, Inc.
HCG
Jun 12, 2015K150319MICRUSFRAME 10/18, DELTAFILL 18, DELTAXSFT 10, GALAXY G3 FILL/XSFT STRETCH RESISTANT MICROCOIL DELIVERY SYSTEMS
Codman & Shurtleff, Inc.
HCG
Mar 18, 2015K143218Penumbra Smart Coil
Penumbra, Inc.
HCG
Dec 24, 2014K142429CODMAN Microcoil Delivery System, DELTAMAXX Microcoil Delivery System, ORBIT GALAXY G2 Microcoil Delivery System, EnPowe
Codman & Shurtleff, Inc.
HCG
Nov 13, 2014K142513Barricade Embolization Coil System
Blockade Medical
HCG
Jul 3, 2014K141134POD SYSTEM
Penumbra, Inc.
HCG
Feb 13, 2014K140104BARRICADE EMBOLIZATION COIL SYSTEM
Blockade Medical
HCG
Jan 10, 2014K133310AXIUM DETACHABLE COIL SYSTEM
Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
HCG

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