HCG
HYDROCOIL EMBOLIC SYSTEM (HES)
- Advisory panel
- Neurology
- Total cleared
- 184
Adverse events under product code HCG
product code HCG- Death
- 50
- Injury
- 801
- Malfunction
- 5,625
- Total
- 6,476
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recent clearances under product code HCG
1–100 of 184- K254221 — Optima Coil System (OptiOne Coil System)
- K252694 — Target Detachable Coil
- K251832 — InZone IST Detachment System; IZDS Connecting Cable
- K252700 — Optima Coil System (Optima Packing Coil System)
- K242154 — Numen Coil Embolization System; NumenFR Detachment System
- K242582 — Optima Coil System (OptiBlock Line Extension)
- K242243 — Target Detachable Coils
- K232955 — Numen Coil Embolization System; NumenFR Detachment System
- K233420 — Axium Detachable Coil; Axium Prime Detachable Coil
- K230284 — Penumbra LP Coil System
- K222533 — Target Tetra Detachable Coils
- K223386 — Optima Coil System
- K220040 — CEREPAK Uniform, Uniform XL, Uniform 3D, Heliform Soft, Heliform XtraSoft, Heliform XL, Heliform XtraSoft XL, Freeform, Freeform Mini, and Freeform XtraSoft Detachable Coil Systems
- K212455 — InZone Detachment System
- K203625 — Numen Coil Embolization System; NumenFR Detachment System
- K203432 — Axium Detachable Coil; Axium Prime Detachable Coil
- K211344 — MICRUSFRAME, DELTAFILL, DELTAXSFT, GALAXY G3, GALAXY G3 XSFT, and GALAXY G3 Mini Microcoil Delivery Systems
- K210638 — i-ED COIL System
- K192068 — i-ED COIL
- K200030 — Optima Coil System
- K192955 — Penumbra LP Coil System
- K180653 — Spartan eCoil System
- K173711 — Wallaby Avenir Coil System
- K173614 — Penumbra Coil 400, Ruby Coil System, POD System
- K172390 — Optima Coil System
- K171862 — GALAXY G3 Mini Microcoil Delivery System
- K170852 — POD Packing Coil
- K171747 — MICRUSFRAME 10 Stretch Resistant Microcoil Delivery System, MICRUSFRAME 18 Stretch Resistant Microcoil Delivery System, DELTAFILL 18 Stretch Resistant Microcoil Delivery System, DELTAXSFT 10 Stretch Resistant Microcoil Delivery System, GALAXY G3 FILL and GALAXY G3 XSFT Stretch Resistant Microcoil Delivery System
- K162999 — V-Grip Detachment Controller for use with Hydrocoil Embolic System and MicroPlex Coil System, AZUR Detachment Controller for use with AZUR Peripheral Coil System
- K162704 — Axium Prime Detachable Coil System
- K161367 — HydroCoil Embolic System (HES)
- K161452 — MicroPlex Coil System (MCS) - HyperSoft 3D
- K161429 — Target Detachable Coils
- K153658 — Target Detachable Coils
- K160832 — Penumbra Smart Coil
- K160096 — InZone Detachment System
- K153594 — MicroPlex Coil System (MCS), Hydrocoil Embolic System (HES)
- K151447 — Axium Detachable Coil System
- K151760 — Barricade Embolization Coil System
- K151572 — Penumbra Smart Coil
- K150319 — MICRUSFRAME 10/18, DELTAFILL 18, DELTAXSFT 10, GALAXY G3 FILL/XSFT STRETCH RESISTANT MICROCOIL DELIVERY SYSTEMS
- K143218 — Penumbra Smart Coil
- K142429 — CODMAN Microcoil Delivery System, DELTAMAXX Microcoil Delivery System, ORBIT GALAXY G2 Microcoil Delivery System, EnPower Control Cable, Connector Cable
- K142513 — Barricade Embolization Coil System
- K141134 — POD SYSTEM
- K140104 — BARRICADE EMBOLIZATION COIL SYSTEM
- K133310 — AXIUM DETACHABLE COIL SYSTEM
- K132952 — MICROPLEX COIL SYSTEM (MCS), HYDROCOIL EMBOLIC SYSTEM (HES)
- K132482 — BARRICADE EMBOLIZATION COIL SYSTEM
- K131948 — MICROPLEX COIL SYSTEM (MCS)
- K132317 — MICROPLEX COIL SYSTEM (MCS), VFC
- K131475 — BARRICADE EMBOLIZATION COIL SYSTEM
- K123338 — BARRICADE EMBOLIZATION COIL SYSTEM
- K123560 — VASCULAR OCCLUSION SYSTEM (TRUFILL PUSHABLE COILS), AND TRUFILL DCS ORBIT DETACHABLE COIL SYSEM
- K123377 — TARGET DETACHABLE COIL
- K120908 — HYDROCOIL EMBOLIC SYSTEM (HES)
- K120850 — TARGET DETACHABLE COIL
- K120686 — ORBIT GALAXY G2 MICROCOIL DELIVERY SYSTEM
- K120330 — PENUMBRA COIL SYSTEM/PENUMBRA COIL 400
- K113822 — QUADRASPHERE 30 TO 60
- K120274 — DELTAMAXX 18 MICROCOIL SYSTEM
- K113457 — HYDROCOIL EMBOLIC SYSTEM (HES)
- K113412 — TARGET DETACHABLE COIL
- K112181 — HYDROCOIL(R) EMBOLIC SYSTEM (HES)
- K112226 — HYDROCOIL EMBOLIC SYSTEM (HES)
- K111451 — MICROPLEX COIL SYSTEM-VECTOR MODEL 030606XXX-V, 030610XXX-V, 30615XXX-V, 061020XXX-V, 061030XXX-V, 101530XXX-V, 101540XX
- K112385 — TRAGET DETACHABLE COIL
- K103758 — MICROPLEX COIL SYSTEM- COSMOS 10, HYDROCOIL SYSTEM- HYDROFRAME 10
- K103355 — GDC 360 DETEACHABLE COIL
- K103305 — PENUMBRA EMBOLIZATION COIL SYSTEM
- K103008 — INZONE DETACHMENT SYSTEM
- K102672 — TARGET DETACHABLE COIL
- K093973 — TRUFILL DCS ORBIT DETACHABLE COIL SYSTEM
- K100454 — HYDROCOIL EMBOLIC SYSTEM-HYDROFRAME MODEL 100931HFM-V, 101243HFM-V, 180827HFM-V, 181139HFM-V, 181445HFM-V, 181850HFM-V
- K094018 — LC BEAD MICROSPHERES, BEAD BLOCK COMPRESSIBLE MICROSPHERES
- K093142 — TARGET DETACHABLE COILS AND INZONE DETACHMENT SYSTEM
- K093919 — MICROPLEX COIL SYSTEM-COSMOS MODEL 100933CSSR-V, 101036CSSR-V, 101141CSSR-V, 101245CSSR-V
- K093358 — MICROPLEX COIL SYSTEM-COSMOS, MODELS 81451CS-V, 181555CS-V, 16=81652CS-V
- K092666 — INZONE DETACHMENT SYSTEM, MODEL M00345100940, IZDS CONNECTING CABLE, MODEL M00345100250
- K091641 — HYDROCOIL EMBOLIC SYSTEM (HYDROSOFT) AND MICROPLEX COIL SYSTEM (HYPERSOFT)
- K090891 — MICROPLEX COIL SYSTEM-COSMOS
- K090357 — HYDROFRAME (HES)
- K090168 — AZUR DETACTABLE 18, MODELS 45-480305, 45-480310, 45-480405, 44-480415
- K090001 — V-GRIP PLUS DETACHMENT CONTROLLER, MODEL VG503
- K083646 — MICRUS MICROCOLI SYSTEM, DELTAPLUSH, MODELS CPL, DPL
- K082739 — MICRUS MICROCOIL DELIVERY SYSTEM
- K082461 — BARE PLATINUM FRAMING COIL, MODEL(S) 100408BPFC-V,100412BPFC-V,100515BPFC-V100518BPFC-V,100522BPFC-V,100618BPFC-V100622B
- K082324 — TRUFILL DCS SYRINGE
- K080666 — HYDROSOFT AND HYDROSOFT PLUS EMBOLIZATION COIL SYSTEMS
- K080379 — MICRUS MICROCOIL SYSTEM, DELTAPAQ 10 STRETCH RESISTANT
- K080437 — MICRUS MICROCOIL SYSTEM, DELTAPAQ 10 CERECYTE, MODEL CDF
- K080967 — TRUFILL DCS ORBIT DETACHABLE COIL AND TRUFILL DCS SYRINGE OR TRUFILL DCS SYRINGE II, ALSO KNOWN AS THE TRUFILL DCS ORBIT
- K073442 — MICRUS MICROCOIL SYSTEMS
- K073419 — PVA PLUS VIAL PVA FOAM EMBOLIZATION PARTICLES, PVA PLUS CONVENIENCE KIT PVA EMBOLIZATION PARTICLES
- K072173 — MICRUS MICROCOIL SYSTEM CASHMERE-CERECYTE, MODEL CRC; CASHMERE-SR, MODEL SRC
- K071962 — VASCULAR OCCLUSION SYSTEM (TRUFILL PUSHABLE COILS AND TRUPUSH COIL PUSHER)
- K071634 — MODIFICATION TO:CONTOUR SE MICROSPHERES
- K070656 — HYDROCOIL EMBOLIC SYSTEM (HES)
- K071246 — MICRUS MICROCOIL DELIVERY SYSTEM, MODELS SPH, HEL, CHE, PC4, HSR, FSR, CSP, CFS, SRC, PP4, STR
- K060747 — FX DETACHABLE COIL SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.