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Miscellaneous
Subpart B—Cardiovascular Diagnostic Devices
CFR Sub-Part
Subpart B—Diagnostic Devices
CFR Sub-Part
Subpart B—Neurological Diagnostic Devices
CFR Sub-Part
Subpart B—Physical Medicine Diagnostic Devices
CFR Sub-Part
Subpart C—Cardiovascular Monitoring Devices
CFR Sub-Part
Subpart D—Physical Medicine Prosthetic Devices
CFR Sub-Part
Subpart E—Neurological Surgical Devices
CFR Sub-Part
Subpart E—Surgical Devices
CFR Sub-Part
Subpart F—Cardiovascular Therapeutic Devices
CFR Sub-Part
Subpart F—Neurological Therapeutic Devices
CFR Sub-Part
GXO
Strip, Craniosynostosis, Preformed
2
Product Code
GXP
Methyl Methacrylate For Cranioplasty
2
Product Code
GXQ
Dura Substitute
2
Product Code
GXR
Cover, Burr Hole
2
Product Code
GXT
Monitor, Lesion Temperature
2
Product Code
GWO
Plate, Cranioplasty, Preformed, Alterable
2
Product Code
GXC
Device, Electroconvulsive Therapy
3
Product Code
GXN
Plate, Cranioplasty, Preformed, Non-Alterable
2
Product Code
GYZ
Stimulator, Intracerebral/Subcortical, Implanted
3
Product Code
GZA
Implanted Cerebellar Stimulator
3
Product Code
GZB
Stimulator, Spinal-Cord, Implanted (Pain Relief)
2
Product Code
GZF
Stimulator, Peripheral Nerve, Implanted (Pain Relief)
2
Product Code
GZI
Stimulator, Neuromuscular, External Functional
2
Product Code
GZJ
Stimulator, Nerve, Transcutaneous, For Pain Relief
2
Product Code
HAX
Tong, Skull For Traction
2
Product Code
HBP
Clip, Implanted Malleable
2
Product Code
HBW
Fastener, Plate, Cranioplasty
2
Product Code
HBZ
Catheter, Intravascular Occluding
3
Product Code
HCB
Device, Aversive Conditioning
2
Product Code
HCC
Device, Biofeedback
2
Product Code
HCE
Clamp, Carotid Artery
2
Product Code
HCG
Device, Neurovascular Embolization
2
Product Code
K
24
2154
Numen™ Coil Embolization System; NumenFR™ Detachment System
2
Cleared 510(K)
K
24
2582
Optima Coil System (OptiBlock Line Extension)
2
Cleared 510(K)
K
24
2243
Target Detachable Coils
2
Cleared 510(K)
K
23
2955
Numen Coil Embolization System; NumenFR Detachment System
2
Cleared 510(K)
K
23
3420
Axium Detachable Coil; Axium Prime Detachable Coil
2
Cleared 510(K)
K
23
0284
Penumbra LP Coil System
2
Cleared 510(K)
K
22
2533
Target Tetra Detachable Coils
2
Cleared 510(K)
K
22
3386
Optima Coil System
2
Cleared 510(K)
K
22
0040
CEREPAK Uniform, Uniform XL, Uniform 3D, Heliform Soft, Heliform XtraSoft, Heliform XL, Heliform XtraSoft XL, Freeform, Freeform Mini, and Freeform XtraSoft Detachable Coil Systems
2
Cleared 510(K)
K
21
2455
InZone Detachment System
2
Cleared 510(K)
K
20
3625
Numen Coil Embolization System; NumenFR Detachment System
2
Cleared 510(K)
K
20
3432
Axium Detachable Coil; Axium Prime Detachable Coil
2
Cleared 510(K)
K
21
1344
MICRUSFRAME, DELTAFILL, DELTAXSFT, GALAXY G3, GALAXY G3 XSFT, and GALAXY G3 Mini Microcoil Delivery Systems
2
Cleared 510(K)
K
21
0638
i-ED COIL System
2
Cleared 510(K)
K
19
2068
i-ED COIL
2
Cleared 510(K)
K
20
0030
Optima Coil System
2
Cleared 510(K)
K
19
2955
Penumbra LP Coil System
2
Cleared 510(K)
K
18
0653
Spartan eCoil System
2
Cleared 510(K)
K
17
3711
Wallaby Avenir Coil System
2
Cleared 510(K)
K
17
3614
Penumbra Coil 400, Ruby Coil System, POD System
2
Cleared 510(K)
K
17
2390
Optima Coil System
2
Cleared 510(K)
K
17
1862
GALAXY G3 Mini Microcoil Delivery System
2
Cleared 510(K)
K
17
0852
POD Packing Coil
2
Cleared 510(K)
K
17
1747
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
2
Cleared 510(K)
K
16
2999
V-Grip Detachment Controller for use with Hydrocoil Embolic System and MicroPlex Coil System, AZUR Detachment Controller for use with AZUR Peripheral Coil System
2
Cleared 510(K)
K
16
2704
Axium Prime Detachable Coil System
2
Cleared 510(K)
K
16
1452
MicroPlex Coil System (MCS) - HyperSoft 3D
2
Cleared 510(K)
K
16
1367
HydroCoil Embolic System (HES)
2
Cleared 510(K)
K
16
1429
Target Detachable Coils
2
Cleared 510(K)
K
15
3658
Target Detachable Coils
2
Cleared 510(K)
K
16
0832
Penumbra Smart Coil
2
Cleared 510(K)
K
16
0096
InZone Detachment System
2
Cleared 510(K)
K
15
3594
MicroPlex Coil System (MCS), Hydrocoil Embolic System (HES)
2
Cleared 510(K)
K
15
1447
Axium Detachable Coil System
2
Cleared 510(K)
K
15
1760
Barricade Embolization Coil System
2
Cleared 510(K)
K
15
1572
Penumbra Smart Coil
2
Cleared 510(K)
K
15
0319
MICRUSFRAME 10/18, DELTAFILL 18, DELTAXSFT 10, GALAXY G3 FILL/XSFT STRETCH RESISTANT MICROCOIL DELIVERY SYSTEMS
2
Cleared 510(K)
K
14
3218
Penumbra Smart Coil
2
Cleared 510(K)
K
14
2429
CODMAN Microcoil Delivery System, DELTAMAXX Microcoil Delivery System, ORBIT GALAXY G2 Microcoil Delivery System, EnPower Control Cable, Connector Cable
2
Cleared 510(K)
K
14
2513
Barricade Embolization Coil System
2
Cleared 510(K)
K
14
1134
POD SYSTEM
2
Cleared 510(K)
K
14
0104
BARRICADE EMBOLIZATION COIL SYSTEM
2
Cleared 510(K)
K
13
3310
AXIUM DETACHABLE COIL SYSTEM
2
Cleared 510(K)
K
13
2952
MICROPLEX COIL SYSTEM (MCS), HYDROCOIL EMBOLIC SYSTEM (HES)
2
Cleared 510(K)
K
13
2482
BARRICADE EMBOLIZATION COIL SYSTEM
2
Cleared 510(K)
K
13
1948
MICROPLEX COIL SYSTEM (MCS)
2
Cleared 510(K)
K
13
2317
MICROPLEX COIL SYSTEM (MCS), VFC
2
Cleared 510(K)
K
13
1475
BARRICADE EMBOLIZATION COIL SYSTEM
2
Cleared 510(K)
K
12
3338
BARRICADE EMBOLIZATION COIL SYSTEM
2
Cleared 510(K)
K
12
3560
VASCULAR OCCLUSION SYSTEM (TRUFILL PUSHABLE COILS), AND TRUFILL DCS ORBIT DETACHABLE COIL SYSEM
2
Cleared 510(K)
K
12
3377
TARGET DETACHABLE COIL
2
Cleared 510(K)
K
12
0908
HYDROCOIL EMBOLIC SYSTEM (HES)
2
Cleared 510(K)
K
12
0850
TARGET DETACHABLE COIL
2
Cleared 510(K)
K
12
0686
ORBIT GALAXY G2 MICROCOIL DELIVERY SYSTEM
2
Cleared 510(K)
K
12
0330
PENUMBRA COIL SYSTEM/PENUMBRA COIL 400
2
Cleared 510(K)
K
11
3822
QUADRASPHERE 30 TO 60
2
Cleared 510(K)
K
12
0274
DELTAMAXX 18 MICROCOIL SYSTEM
2
Cleared 510(K)
K
11
3457
HYDROCOIL EMBOLIC SYSTEM (HES)
2
Cleared 510(K)
K
11
3412
TARGET DETACHABLE COIL
2
Cleared 510(K)
K
11
2181
HYDROCOIL(R) EMBOLIC SYSTEM (HES)
2
Cleared 510(K)
K
11
2226
HYDROCOIL EMBOLIC SYSTEM (HES)
2
Cleared 510(K)
K
11
1451
MICROPLEX COIL SYSTEM-VECTOR MODEL 030606XXX-V, 030610XXX-V, 30615XXX-V, 061020XXX-V, 061030XXX-V, 101530XXX-V, 101540XX
2
Cleared 510(K)
K
11
2385
TRAGET DETACHABLE COIL
2
Cleared 510(K)
K
10
3758
MICROPLEX COIL SYSTEM- COSMOS 10, HYDROCOIL SYSTEM- HYDROFRAME 10
2
Cleared 510(K)
K
10
3355
GDC 360 DETEACHABLE COIL
2
Cleared 510(K)
K
10
3305
PENUMBRA EMBOLIZATION COIL SYSTEM
2
Cleared 510(K)
K
10
3008
INZONE DETACHMENT SYSTEM
2
Cleared 510(K)
K
10
2672
TARGET DETACHABLE COIL
2
Cleared 510(K)
K
09
3973
TRUFILL DCS ORBIT DETACHABLE COIL SYSTEM
2
Cleared 510(K)
K
10
0454
HYDROCOIL EMBOLIC SYSTEM-HYDROFRAME MODEL 100931HFM-V, 101243HFM-V, 180827HFM-V, 181139HFM-V, 181445HFM-V, 181850HFM-V
2
Cleared 510(K)
K
09
4018
LC BEAD MICROSPHERES, BEAD BLOCK COMPRESSIBLE MICROSPHERES
2
Cleared 510(K)
K
09
3142
TARGET DETACHABLE COILS AND INZONE DETACHMENT SYSTEM
2
Cleared 510(K)
K
09
3919
MICROPLEX COIL SYSTEM-COSMOS MODEL 100933CSSR-V, 101036CSSR-V, 101141CSSR-V, 101245CSSR-V
2
Cleared 510(K)
K
09
3358
MICROPLEX COIL SYSTEM-COSMOS, MODELS 81451CS-V, 181555CS-V, 16=81652CS-V
2
Cleared 510(K)
K
09
2666
INZONE DETACHMENT SYSTEM, MODEL M00345100940, IZDS CONNECTING CABLE, MODEL M00345100250
2
Cleared 510(K)
K
09
1641
HYDROCOIL EMBOLIC SYSTEM (HYDROSOFT) AND MICROPLEX COIL SYSTEM (HYPERSOFT)
2
Cleared 510(K)
K
09
0891
MICROPLEX COIL SYSTEM-COSMOS
2
Cleared 510(K)
K
09
0357
HYDROFRAME (HES)
2
Cleared 510(K)
K
09
0168
AZUR DETACTABLE 18, MODELS 45-480305, 45-480310, 45-480405, 44-480415
2
Cleared 510(K)
K
09
0001
V-GRIP PLUS DETACHMENT CONTROLLER, MODEL VG503
2
Cleared 510(K)
K
08
3646
MICRUS MICROCOLI SYSTEM, DELTAPLUSH, MODELS CPL, DPL
2
Cleared 510(K)
K
08
2739
MICRUS MICROCOIL DELIVERY SYSTEM
2
Cleared 510(K)
K
08
2461
BARE PLATINUM FRAMING COIL, MODEL(S) 100408BPFC-V,100412BPFC-V,100515BPFC-V100518BPFC-V,100522BPFC-V,100618BPFC-V100622B
2
Cleared 510(K)
K
08
2324
TRUFILL DCS SYRINGE
2
Cleared 510(K)
K
08
0666
HYDROSOFT AND HYDROSOFT PLUS EMBOLIZATION COIL SYSTEMS
2
Cleared 510(K)
K
08
0379
MICRUS MICROCOIL SYSTEM, DELTAPAQ 10 STRETCH RESISTANT
2
Cleared 510(K)
K
08
0437
MICRUS MICROCOIL SYSTEM, DELTAPAQ 10 CERECYTE, MODEL CDF
2
Cleared 510(K)
K
08
0967
TRUFILL DCS ORBIT DETACHABLE COIL AND TRUFILL DCS SYRINGE OR TRUFILL DCS SYRINGE II, ALSO KNOWN AS THE TRUFILL DCS ORBIT
2
Cleared 510(K)
K
07
3442
MICRUS MICROCOIL SYSTEMS
2
Cleared 510(K)
K
07
3419
PVA PLUS VIAL PVA FOAM EMBOLIZATION PARTICLES, PVA PLUS CONVENIENCE KIT PVA EMBOLIZATION PARTICLES
2
Cleared 510(K)
K
07
2173
MICRUS MICROCOIL SYSTEM CASHMERE-CERECYTE, MODEL CRC; CASHMERE-SR, MODEL SRC
2
Cleared 510(K)
K
07
1962
VASCULAR OCCLUSION SYSTEM (TRUFILL PUSHABLE COILS AND TRUPUSH COIL PUSHER)
2
Cleared 510(K)
K
07
1634
MODIFICATION TO:CONTOUR SE MICROSPHERES
2
Cleared 510(K)
K
07
0656
HYDROCOIL EMBOLIC SYSTEM (HES)
2
Cleared 510(K)
K
07
1246
MICRUS MICROCOIL DELIVERY SYSTEM, MODELS SPH, HEL, CHE, PC4, HSR, FSR, CSP, CFS, SRC, PP4, STR
2
Cleared 510(K)
K
06
0747
FX DETACHABLE COIL SYSTEM
2
Cleared 510(K)
K
07
0707
MICRUS MICROCOIL SYSTEM
2
Cleared 510(K)
K
06
3653
MICRUS MICROCOIL SYSTEM, CASHMERE MODEL SRC
2
Cleared 510(K)
K
05
2509
M-BOLUS EMBOLIC MICROSPHERES
2
Cleared 510(K)
K
06
3254
THE TRUFILL DCS DETACHABLE COIL SYSTEM; THE TRUFILL DCS ORBIT DETACHABLE COIL SYSTEM
2
Cleared 510(K)
K
06
2036
MICRUS MICROCOIL SYSTEM PRESIDIO-18, MODEL PC4
2
Cleared 510(K)
K
06
0625
NEXUS DETACHABLE COIL SYSTEM, MORPHEUS 3D CSR
2
Cleared 510(K)
K
05
3548
MODIFIED PVA-PLUS FOAM EMBOLIZATION PARTICLES AND MAXISTAT AND MICROSTAT PVA FOAM EMBOLIZATION PARTICLES
2
Cleared 510(K)
K
05
3197
TRUFILL DCS ORBIT DETACHABLE COIL SYSTEM LINE EXTENSION
2
Cleared 510(K)
K
05
3160
MICRUS MODIFIED MICROCOIL 18-SYSTEM, CERECYTE, MODEL CSP & CHE
2
Cleared 510(K)
K
05
1560
NEXUS DETACHABLE COIL, MULTI-DIAMETER CSR AND HELIX SUPER SOFT CSR
2
Cleared 510(K)
K
05
0954
MICROPLEX COIL SYSTEM (MCS) AND HYDROCOIL EMBOLIC SYSTEM (HES)
2
Cleared 510(K)
K
05
1425
NEXUS DETACHABLE COIL SYSTEM, HELIX SUPER SOFT CSR
2
Cleared 510(K)
K
04
2297
ULTRA IVALON AND ULTRA DRIVALON PVA EMBOLIZATION PARTICLES
2
Cleared 510(K)
K
05
0543
NEXUS DETACHABLE COIL SYSTEM
2
Cleared 510(K)
K
05
0700
MATRIX STRETCH RESISTANT (SR) COILS
2
Cleared 510(K)
K
04
2231
GELSPHERES MICROSPHERES AND BEAD BLOCK COMPRESSIBLE MICROSPHERES
2
Cleared 510(K)
K
04
2539
GDC-10 360 DEGREE COIL SR; GDC-10 360 DEGREE SOFT COIL SR; GDC-18 360 DEGREE COIL
2
Cleared 510(K)
K
04
1649
SAPPHIRE NXT DETACHABLE COIL SYSTEM
2
Cleared 510(K)
K
04
1551
MODIFICATION TO: HYDROCOIL EMBOLIC SYSTEM (HES)
2
Cleared 510(K)
K
04
0694
MODIFICATION TO SAPPHIRE DETACHABLE COIL SYSTEM (TETRIS 3-D)
2
Cleared 510(K)
K
03
2619
MICROSTAT PVA FOAM EMBOLIZATION PARTICLES
2
Cleared 510(K)
K
03
3813
MICRUS MODIFIED MICROCOIL SYSTEM, CERECYTE
2
Cleared 510(K)
K
03
3761
GELSPHERES / BEADBLOCK COMPRESSIBLE MICROSPHERES
2
Cleared 510(K)
K
03
3372
SAPPHIRE DETACHABLE FIBERED COIL SYSTEM, HELIX FIBERED, CYCLONE, MULTIPLE MODELS
2
Cleared 510(K)
K
03
3836
HYDROCOIL EMBOLIC SYSTEM (HES)
2
Cleared 510(K)
K
03
2872
MICRUS MICROCOIL SYSTEM
2
Cleared 510(K)
K
03
2590
MICROPLEX COIL SYSTEM (MCS), HYDROCOIL EMBOLIC SYSTEM (HES)
2
Cleared 510(K)
K
03
2497
SAPPHIRE VDS TENSION SAFE DETACHABLE COIL, E-3-12/3-T10-VT
2
Cleared 510(K)
K
03
2707
CONTOUR SE MICROSPHERES (SYRINGE)
2
Cleared 510(K)
K
03
2553
TRUFILL DCS ORBIT DETACHABLE COIL AND TRUFILL DCS SYRINGE, ALSO KNOWN AS TRUFILL DCS ORBIT DETACHABLE COIL SYSTEM
2
Cleared 510(K)
K
03
2542
MODIFICATION TO CONTOUR SE MICROSPHERES
2
Cleared 510(K)
K
03
1852
SAPPHIRE DETACHABLE FIBER COILS
2
Cleared 510(K)
K
03
1578
MICRUS MICROCOIL SYSTEMS, MODELS HEL, SPH, STR, FSR AND HSR
2
Cleared 510(K)
K
03
1049
GUGLIELMI DETACHABLE COIL (GDC)
2
Cleared 510(K)
K
03
0392
SAPPHIRE DETACHABLE COIL SYSTEM
2
Cleared 510(K)
K
03
0963
TRUFILL DCS ORBIT DETACHABLE COIL AND TRUFILL DCS SYRINGE, ALSO KNOWN AS THE TRUFILL DCS ORBIT DETACHABLE COIL SYSTEM
2
Cleared 510(K)
K
03
1168
MATRIX STRETCH RESISTANT DETACHABLE COIL
2
Cleared 510(K)
K
03
0475
GDC STRETCH RESISTANT DETACHABLE COIL
2
Cleared 510(K)
K
02
3089
GELSPHERES EMBOLIC AGENT
2
Cleared 510(K)
K
02
2420
MICRUS STRETCH-RESISTANT MICROCOIL SYSTEM, MSR01
2
Cleared 510(K)
K
02
2735
MICROPLEX COIL SYSTEM (MCS) AND HYDROCOIL EMBOLIC SYSTEM (HES) WITH THE HYDROLINK SYRINGE KIT
2
Cleared 510(K)
K
02
2427
CONTOUR SE MICROSPHERES
2
Cleared 510(K)
K
02
0434
MICROPLEX COIL SYSTEM (MCS)
2
Cleared 510(K)
K
02
1914
MICROPLEX COIL SYSTEMS (MCS)
2
Cleared 510(K)
K
02
1494
GDC POWER SUPPLY, MODEL GDC POWER SUPPLY: 451007-4
2
Cleared 510(K)
K
02
0033
MAXISTAT PVA FOAM EMBOLIZATION PARTICLES
2
Cleared 510(K)
K
01
4041
TRUFILL DCS DETACHABLE COIL AND FRUFILL DCS SYRINGE, ALSO KNOWN AS THE TRUFILL DCS DETACHABLE COIL SYSTEM
2
Cleared 510(K)
K
01
2985
MATRIX DETACHABLE COILS
2
Cleared 510(K)
K
01
2145
MICROPLEX COIL SYSTEM
2
Cleared 510(K)
K
01
0026
EMBOGOLD MICROSPHERE
2
Cleared 510(K)
K
00
1678
PVA FOAM EMBOLIZATION PARTICLES
2
Cleared 510(K)
K
00
2056
MICRUS MICROCOIL DELIVERY SYSTEM, MDS03
2
Cleared 510(K)
K
00
0651
DETACH 18 AND DETACH 11, NEUROLOGICAL EMBOLIZATION COIL SYSTEM
2
Cleared 510(K)
K
00
2181
GDC ULTRASOFT COIL
2
Cleared 510(K)
K
00
1083
GUGLIELMI DETACHABLE COIL AND POWER SUPPLY, MODELS POWER SUPPLY : 451006-4; CABLES: 451102-4
2
Cleared 510(K)
K
99
1549
EMBOSPHERE MICROSPHERES
2
Cleared 510(K)
K
99
3415
GDC-10 STRETCH RESISTANT GUGLIELMI DETACHABLE COIL, GDC-10 2-DIAMETER STRETCH RESISTANT GUGLIELMI DETACHABLE COIL, GDC-1
2
Cleared 510(K)
K
99
3417
GDC-10 GUGLIELMI DETACHABLE COIL (GDC) (3D SHAPE GDC), GDC-18 GUGLIELMI DETACHABLE COIL (GDC) (3D SHAPE GDC)
2
Cleared 510(K)
K
99
3418
FIBERED GDC-18 VORTX SHAPE GUGLIELMI DETACHABLE COIL
2
Cleared 510(K)
K
99
1139
GUGLIELMI DETACHABLE (GDC)
2
Cleared 510(K)
K
98
3483
VASCULAR OCCLUSION SYSTEM
2
Cleared 510(K)
K
97
2881
CES VASCULAR OCCLUSION SYSTEM
2
Cleared 510(K)
K
96
4021
INTRAMED SIDE BRANCH OCCLUSION (SBO) SYSTEM (700095 AND 700099)
2
Cleared 510(K)
K
96
5174
TRUFILL PVA PARTICLES
2
Cleared 510(K)
K
96
4367
CES VASCULAR OCCLUSION SYSTEM
2
Cleared 510(K)
K
96
3307
GDC PATIENT RETURN ELECTTRODE MODEL 45021
2
Cleared 510(K)
K
96
2503
GUGLIELMI DETACHABLE COIL
2
Cleared 510(K)
K
96
1923
BERENSTEIN COIL
2
Cleared 510(K)
K
96
0705
GUGLIELMI DETACHABLE COIL
2
Cleared 510(K)
K
95
1256
DETACHABLE PLATINUM COIL (GUGLIELMI DETACHABLE COIL, GDC)
2
Cleared 510(K)
K
95
1314
TRUEFILL PVA PARTICLES
2
Cleared 510(K)
K
94
4354
CONTOUR EMBOLI
2
Cleared 510(K)
K
91
3556
IVALON EMBOLIZATION PARTICLES
2
Cleared 510(K)
K
91
4866
ITC CONTOUR EMBOLI, MODIFICATION
2
Cleared 510(K)
K
92
5876
ITC BUNJI PLATINUM EMBOLIZATION COIL
2
Cleared 510(K)
K
92
5523
ITC BUNJI PLATINUM EMBOLIZATION COIL
2
Cleared 510(K)
K
92
0324
ITC BUNJI COIL (MODIFICATION)
2
Cleared 510(K)
K
91
3312
HELIX SHAPED COILS WITH DACRON FIBERS, MODIFIED
2
Cleared 510(K)
K
91
1779
HELIX SHAPED COILS WITH DACRON FIBERS, MODIFIED
2
Cleared 510(K)
K
90
0723
ITC BUNJI COIL
2
Cleared 510(K)
K
90
1337
HILAL EMBOLIZATION MICROCOIL(TM)
2
Cleared 510(K)
K
90
1721
MODIFIED TARGET THERAPEUTICS COILS
2
Cleared 510(K)
K
89
1688
COIL AND COIL DELIVERY SYSTEM
2
Cleared 510(K)
K
87
1047
RADIOPAQUE SPHERICAL EMBOLI (RSE)
2
Cleared 510(K)
HCH
Clip, Aneurysm
2
Product Code
JXG
Shunt, Central Nervous System And Components
2
Product Code
JXH
Methyl Methacrylate For Aneurysmorrhaphy
2
Product Code
JXI
Cuff, Nerve
2
Product Code
JXK
Cranial Electrotherapy Stimulator To Treat Depression
3
Product Code
JXL
Block, Bite
2
Product Code
LEL
Device, Sleep Assessment
2
Product Code
LHG
Electrode, Spinal Epidural
2
Product Code
LIH
Interferential Current Therapy
2
Product Code
MVA
Orthosis, Cranial
2
Product Code
MYU
Accessory, Barium Sulfate, Methyl Methacrylate For Cranioplasty
2
Product Code
MZQ
Balloon, Detachable, For Neurovascular Occlusion
2
Product Code
NFO
Stimulator, Transcutaneous Electrical, Aesthetic Purposes
2
Product Code
NHI
Stimulator, Nerve, Electrical, Percutaneous (Pens), For Pain Relief
2
Product Code
NUF
Catheter, Neurovasculature, Occluding Balloon
3
Product Code
NUH
Stimulator, Nerve, Transcutaneous, Over-The-Counter
2
Product Code
NYN
Stimulator, Electrical, Transcutaneous, For Arthritis
2
Product Code
NYW
Stimulator, Nerve, Electrical, Transcutaneous, With Limited Output, For Pain Relief
2
Product Code
NYX
Stimulator, Electrical, Transcutaneous, With Limited Output, For Aesthetic Purposes
2
Product Code
OAN
Orthosis, Cranial, Laser Scan
2
Product Code
OBP
Transcranial Magnetic Stimulator
2
Product Code
OBV
Eating Disorder Conditioning Tool
2
Product Code
OCF
Stimulator, Nerve, Electrical, Transcutaneous, Limited Output, Arthritis Pain Relief
2
Product Code
OKP
Transcranial Magnetic Stimulator For The Treatment Of Migraine Headache
2
Product Code
QMD
Transcranial Magnetic Stimulation System For Smoking Cessation
2
Product Code
OSG
Piezo-Electric Stimulator For Relief Of Mosquito Bite Itch
2
Product Code
PAV
Catheter, Neuro-Vasculature, Occluding Balloon
F
Product Code
PBJ
Cranial Distraction System
2
Product Code
PCB
External Cerebrospinal Fluid (Csf) Diversion
2
Product Code
PCC
Stimulator, Nerve, Electrical, Transcutaneous, For Migraine
2
Product Code
PJM
Filler, Bone Void, Alterable Compound For Cranioplasty
2
Product Code
PJN
Filler, Bone Void, Non-Alterable Compound For Cranioplasty
2
Product Code
PKR
Non-Invasive Vagus Nerve Stimulator - Headache
2
Product Code
PLU
Thermal System For Insomnia
2
Product Code
POL
Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment
2
Product Code
PUU
Temporary Coil Embolization Assist Device
2
Product Code
PVL
Endoscopic Shunt Placement Kit
2
Product Code
PVO
Lumbar Drainage Catheter Kit
2
Product Code
PWE
Computerized Behavioral Therapy Device For Psychiatric Disorders
2
Product Code
PZR
Percutaneous Nerve Stimulator For Opioid Withdrawal
2
Product Code
QAK
Non-Invasive Vagus Nerve Stimulator For Migraine Headache
2
Product Code
QAR
Thermal Vestibular Stimulator For Headache
2
Product Code
QBC
External Upper Limb Tremor Stimulator
2
Product Code
QCI
Transcranial Magnetic Stimulation System For Obsessive-Compulsive Disorder
2
Product Code
QFD
Tens For Sinus Pain
2
Product Code
QFF
Electromechanical Arm For A Transcranial Magnetic Stimulation System
2
Product Code
QGH
Electroconvulsive Therapy Device For Catatonia, Major Depressive Disorder, And Bipolar Disorder
2
Product Code
QGL
Transcutaneous Nerve Stimulator For Adhd
2
Product Code
QGT
Distal Transcutaneous Electrical Stimulator For Treatment Of Acute Migraine
2
Product Code
QJQ
Cranial Electrotherapy Stimulator To Treat Insomnia And/Or Anxiety
2
Product Code
QMZ
Digital Therapy Device To Reduce Sleep Disturbance For Psychiatric Conditions
2
Product Code
QQC
Brain Stimulation Programming Planning Software.
2
Product Code
QFT
Digital Therapeutic Software For Attention Deficit Hyperactivity Disorder
2
Product Code
OVP
Vibratory Counter-Stimulation
2
Product Code
QVO
Computerized Behavioral Therapy Device For Insomnia
2
Product Code
SAP
Computerized Behavioral Therapy Device For Depressive Disorders.
2
Product Code
SCP
Computerized Behavioral Therapy Device For Anxiety Disorders
2
Product Code
Subpart F—Physical Medicine Therapeutic Devices
CFR Sub-Part
Subpart F—Therapeutic Devices
CFR Sub-Part
Obstetrical and Gynecological
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Ophthalmic
Review Panel
Orthopedic
Review Panel
Pathology
Review Panel
Physical Medicine
Review Panel
Radiology
Review Panel
General and Plastic Surgery
Review Panel
Toxicology
Review Panel
Medical Genetics
Review Panel
Unknown
Review Panel
Last synced on 30 November 2024 at 11:09 am
NE
/
subpart-f—neurological-therapeutic-devices
/
HCG
/
K033761
View Source
GELSPHERES / BEADBLOCK COMPRESSIBLE MICROSPHERES
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K033761
510(k) Type
Traditional
Applicant
BIOCOMPATIBLES U.K. LIMITED
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
2/4/2004
Days to Decision
64 days
Submission Type
Summary
FDA Browser
by
Innolitics
Anesthesiology
Cardiovascular
Chemistry
Dental
Ear, Nose, Throat
Gastroenterology and Urology
General Hospital
Hematology
Immunology
Microbiology
Neurology
Miscellaneous
Subpart B—Cardiovascular Diagnostic Devices
Subpart B—Diagnostic Devices
Subpart B—Neurological Diagnostic Devices
Subpart B—Physical Medicine Diagnostic Devices
Subpart C—Cardiovascular Monitoring Devices
Subpart D—Physical Medicine Prosthetic Devices
Subpart E—Neurological Surgical Devices
Subpart E—Surgical Devices
Subpart F—Cardiovascular Therapeutic Devices
Subpart F—Neurological Therapeutic Devices
GXO
Strip, Craniosynostosis, Preformed
GXP
Methyl Methacrylate For Cranioplasty
GXQ
Dura Substitute
GXR
Cover, Burr Hole
GXT
Monitor, Lesion Temperature
GWO
Plate, Cranioplasty, Preformed, Alterable
GXC
Device, Electroconvulsive Therapy
GXN
Plate, Cranioplasty, Preformed, Non-Alterable
GYZ
Stimulator, Intracerebral/Subcortical, Implanted
GZA
Implanted Cerebellar Stimulator
GZB
Stimulator, Spinal-Cord, Implanted (Pain Relief)
GZF
Stimulator, Peripheral Nerve, Implanted (Pain Relief)
GZI
Stimulator, Neuromuscular, External Functional
GZJ
Stimulator, Nerve, Transcutaneous, For Pain Relief
HAX
Tong, Skull For Traction
HBP
Clip, Implanted Malleable
HBW
Fastener, Plate, Cranioplasty
HBZ
Catheter, Intravascular Occluding
HCB
Device, Aversive Conditioning
HCC
Device, Biofeedback
HCE
Clamp, Carotid Artery
HCG
Device, Neurovascular Embolization
K
24
2154
Numen™ Coil Embolization System; NumenFR™ Detachment System
K
24
2582
Optima Coil System (OptiBlock Line Extension)
K
24
2243
Target Detachable Coils
K
23
2955
Numen Coil Embolization System; NumenFR Detachment System
K
23
3420
Axium Detachable Coil; Axium Prime Detachable Coil
K
23
0284
Penumbra LP Coil System
K
22
2533
Target Tetra Detachable Coils
K
22
3386
Optima Coil System
K
22
0040
CEREPAK Uniform, Uniform XL, Uniform 3D, Heliform Soft, Heliform XtraSoft, Heliform XL, Heliform XtraSoft XL, Freeform, Freeform Mini, and Freeform XtraSoft Detachable Coil Systems
K
21
2455
InZone Detachment System
K
20
3625
Numen Coil Embolization System; NumenFR Detachment System
K
20
3432
Axium Detachable Coil; Axium Prime Detachable Coil
K
21
1344
MICRUSFRAME, DELTAFILL, DELTAXSFT, GALAXY G3, GALAXY G3 XSFT, and GALAXY G3 Mini Microcoil Delivery Systems
K
21
0638
i-ED COIL System
K
19
2068
i-ED COIL
K
20
0030
Optima Coil System
K
19
2955
Penumbra LP Coil System
K
18
0653
Spartan eCoil System
K
17
3711
Wallaby Avenir Coil System
K
17
3614
Penumbra Coil 400, Ruby Coil System, POD System
K
17
2390
Optima Coil System
K
17
1862
GALAXY G3 Mini Microcoil Delivery System
K
17
0852
POD Packing Coil
K
17
1747
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
K
16
2999
V-Grip Detachment Controller for use with Hydrocoil Embolic System and MicroPlex Coil System, AZUR Detachment Controller for use with AZUR Peripheral Coil System
K
16
2704
Axium Prime Detachable Coil System
K
16
1452
MicroPlex Coil System (MCS) - HyperSoft 3D
K
16
1367
HydroCoil Embolic System (HES)
K
16
1429
Target Detachable Coils
K
15
3658
Target Detachable Coils
K
16
0832
Penumbra Smart Coil
K
16
0096
InZone Detachment System
K
15
3594
MicroPlex Coil System (MCS), Hydrocoil Embolic System (HES)
K
15
1447
Axium Detachable Coil System
K
15
1760
Barricade Embolization Coil System
K
15
1572
Penumbra Smart Coil
K
15
0319
MICRUSFRAME 10/18, DELTAFILL 18, DELTAXSFT 10, GALAXY G3 FILL/XSFT STRETCH RESISTANT MICROCOIL DELIVERY SYSTEMS
K
14
3218
Penumbra Smart Coil
K
14
2429
CODMAN Microcoil Delivery System, DELTAMAXX Microcoil Delivery System, ORBIT GALAXY G2 Microcoil Delivery System, EnPower Control Cable, Connector Cable
K
14
2513
Barricade Embolization Coil System
K
14
1134
POD SYSTEM
K
14
0104
BARRICADE EMBOLIZATION COIL SYSTEM
K
13
3310
AXIUM DETACHABLE COIL SYSTEM
K
13
2952
MICROPLEX COIL SYSTEM (MCS), HYDROCOIL EMBOLIC SYSTEM (HES)
K
13
2482
BARRICADE EMBOLIZATION COIL SYSTEM
K
13
1948
MICROPLEX COIL SYSTEM (MCS)
K
13
2317
MICROPLEX COIL SYSTEM (MCS), VFC
K
13
1475
BARRICADE EMBOLIZATION COIL SYSTEM
K
12
3338
BARRICADE EMBOLIZATION COIL SYSTEM
K
12
3560
VASCULAR OCCLUSION SYSTEM (TRUFILL PUSHABLE COILS), AND TRUFILL DCS ORBIT DETACHABLE COIL SYSEM
K
12
3377
TARGET DETACHABLE COIL
K
12
0908
HYDROCOIL EMBOLIC SYSTEM (HES)
K
12
0850
TARGET DETACHABLE COIL
K
12
0686
ORBIT GALAXY G2 MICROCOIL DELIVERY SYSTEM
K
12
0330
PENUMBRA COIL SYSTEM/PENUMBRA COIL 400
K
11
3822
QUADRASPHERE 30 TO 60
K
12
0274
DELTAMAXX 18 MICROCOIL SYSTEM
K
11
3457
HYDROCOIL EMBOLIC SYSTEM (HES)
K
11
3412
TARGET DETACHABLE COIL
K
11
2181
HYDROCOIL(R) EMBOLIC SYSTEM (HES)
K
11
2226
HYDROCOIL EMBOLIC SYSTEM (HES)
K
11
1451
MICROPLEX COIL SYSTEM-VECTOR MODEL 030606XXX-V, 030610XXX-V, 30615XXX-V, 061020XXX-V, 061030XXX-V, 101530XXX-V, 101540XX
K
11
2385
TRAGET DETACHABLE COIL
K
10
3758
MICROPLEX COIL SYSTEM- COSMOS 10, HYDROCOIL SYSTEM- HYDROFRAME 10
K
10
3355
GDC 360 DETEACHABLE COIL
K
10
3305
PENUMBRA EMBOLIZATION COIL SYSTEM
K
10
3008
INZONE DETACHMENT SYSTEM
K
10
2672
TARGET DETACHABLE COIL
K
09
3973
TRUFILL DCS ORBIT DETACHABLE COIL SYSTEM
K
10
0454
HYDROCOIL EMBOLIC SYSTEM-HYDROFRAME MODEL 100931HFM-V, 101243HFM-V, 180827HFM-V, 181139HFM-V, 181445HFM-V, 181850HFM-V
K
09
4018
LC BEAD MICROSPHERES, BEAD BLOCK COMPRESSIBLE MICROSPHERES
K
09
3142
TARGET DETACHABLE COILS AND INZONE DETACHMENT SYSTEM
K
09
3919
MICROPLEX COIL SYSTEM-COSMOS MODEL 100933CSSR-V, 101036CSSR-V, 101141CSSR-V, 101245CSSR-V
K
09
3358
MICROPLEX COIL SYSTEM-COSMOS, MODELS 81451CS-V, 181555CS-V, 16=81652CS-V
K
09
2666
INZONE DETACHMENT SYSTEM, MODEL M00345100940, IZDS CONNECTING CABLE, MODEL M00345100250
K
09
1641
HYDROCOIL EMBOLIC SYSTEM (HYDROSOFT) AND MICROPLEX COIL SYSTEM (HYPERSOFT)
K
09
0891
MICROPLEX COIL SYSTEM-COSMOS
K
09
0357
HYDROFRAME (HES)
K
09
0168
AZUR DETACTABLE 18, MODELS 45-480305, 45-480310, 45-480405, 44-480415
K
09
0001
V-GRIP PLUS DETACHMENT CONTROLLER, MODEL VG503
K
08
3646
MICRUS MICROCOLI SYSTEM, DELTAPLUSH, MODELS CPL, DPL
K
08
2739
MICRUS MICROCOIL DELIVERY SYSTEM
K
08
2461
BARE PLATINUM FRAMING COIL, MODEL(S) 100408BPFC-V,100412BPFC-V,100515BPFC-V100518BPFC-V,100522BPFC-V,100618BPFC-V100622B
K
08
2324
TRUFILL DCS SYRINGE
K
08
0666
HYDROSOFT AND HYDROSOFT PLUS EMBOLIZATION COIL SYSTEMS
K
08
0379
MICRUS MICROCOIL SYSTEM, DELTAPAQ 10 STRETCH RESISTANT
K
08
0437
MICRUS MICROCOIL SYSTEM, DELTAPAQ 10 CERECYTE, MODEL CDF
K
08
0967
TRUFILL DCS ORBIT DETACHABLE COIL AND TRUFILL DCS SYRINGE OR TRUFILL DCS SYRINGE II, ALSO KNOWN AS THE TRUFILL DCS ORBIT
K
07
3442
MICRUS MICROCOIL SYSTEMS
K
07
3419
PVA PLUS VIAL PVA FOAM EMBOLIZATION PARTICLES, PVA PLUS CONVENIENCE KIT PVA EMBOLIZATION PARTICLES
K
07
2173
MICRUS MICROCOIL SYSTEM CASHMERE-CERECYTE, MODEL CRC; CASHMERE-SR, MODEL SRC
K
07
1962
VASCULAR OCCLUSION SYSTEM (TRUFILL PUSHABLE COILS AND TRUPUSH COIL PUSHER)
K
07
1634
MODIFICATION TO:CONTOUR SE MICROSPHERES
K
07
0656
HYDROCOIL EMBOLIC SYSTEM (HES)
K
07
1246
MICRUS MICROCOIL DELIVERY SYSTEM, MODELS SPH, HEL, CHE, PC4, HSR, FSR, CSP, CFS, SRC, PP4, STR
K
06
0747
FX DETACHABLE COIL SYSTEM
K
07
0707
MICRUS MICROCOIL SYSTEM
K
06
3653
MICRUS MICROCOIL SYSTEM, CASHMERE MODEL SRC
K
05
2509
M-BOLUS EMBOLIC MICROSPHERES
K
06
3254
THE TRUFILL DCS DETACHABLE COIL SYSTEM; THE TRUFILL DCS ORBIT DETACHABLE COIL SYSTEM
K
06
2036
MICRUS MICROCOIL SYSTEM PRESIDIO-18, MODEL PC4
K
06
0625
NEXUS DETACHABLE COIL SYSTEM, MORPHEUS 3D CSR
K
05
3548
MODIFIED PVA-PLUS FOAM EMBOLIZATION PARTICLES AND MAXISTAT AND MICROSTAT PVA FOAM EMBOLIZATION PARTICLES
K
05
3197
TRUFILL DCS ORBIT DETACHABLE COIL SYSTEM LINE EXTENSION
K
05
3160
MICRUS MODIFIED MICROCOIL 18-SYSTEM, CERECYTE, MODEL CSP & CHE
K
05
1560
NEXUS DETACHABLE COIL, MULTI-DIAMETER CSR AND HELIX SUPER SOFT CSR
K
05
0954
MICROPLEX COIL SYSTEM (MCS) AND HYDROCOIL EMBOLIC SYSTEM (HES)
K
05
1425
NEXUS DETACHABLE COIL SYSTEM, HELIX SUPER SOFT CSR
K
04
2297
ULTRA IVALON AND ULTRA DRIVALON PVA EMBOLIZATION PARTICLES
K
05
0543
NEXUS DETACHABLE COIL SYSTEM
K
05
0700
MATRIX STRETCH RESISTANT (SR) COILS
K
04
2231
GELSPHERES MICROSPHERES AND BEAD BLOCK COMPRESSIBLE MICROSPHERES
K
04
2539
GDC-10 360 DEGREE COIL SR; GDC-10 360 DEGREE SOFT COIL SR; GDC-18 360 DEGREE COIL
K
04
1649
SAPPHIRE NXT DETACHABLE COIL SYSTEM
K
04
1551
MODIFICATION TO: HYDROCOIL EMBOLIC SYSTEM (HES)
K
04
0694
MODIFICATION TO SAPPHIRE DETACHABLE COIL SYSTEM (TETRIS 3-D)
K
03
2619
MICROSTAT PVA FOAM EMBOLIZATION PARTICLES
K
03
3813
MICRUS MODIFIED MICROCOIL SYSTEM, CERECYTE
K
03
3761
GELSPHERES / BEADBLOCK COMPRESSIBLE MICROSPHERES
K
03
3372
SAPPHIRE DETACHABLE FIBERED COIL SYSTEM, HELIX FIBERED, CYCLONE, MULTIPLE MODELS
K
03
3836
HYDROCOIL EMBOLIC SYSTEM (HES)
K
03
2872
MICRUS MICROCOIL SYSTEM
K
03
2590
MICROPLEX COIL SYSTEM (MCS), HYDROCOIL EMBOLIC SYSTEM (HES)
K
03
2497
SAPPHIRE VDS TENSION SAFE DETACHABLE COIL, E-3-12/3-T10-VT
K
03
2707
CONTOUR SE MICROSPHERES (SYRINGE)
K
03
2553
TRUFILL DCS ORBIT DETACHABLE COIL AND TRUFILL DCS SYRINGE, ALSO KNOWN AS TRUFILL DCS ORBIT DETACHABLE COIL SYSTEM
K
03
2542
MODIFICATION TO CONTOUR SE MICROSPHERES
K
03
1852
SAPPHIRE DETACHABLE FIBER COILS
K
03
1578
MICRUS MICROCOIL SYSTEMS, MODELS HEL, SPH, STR, FSR AND HSR
K
03
1049
GUGLIELMI DETACHABLE COIL (GDC)
K
03
0392
SAPPHIRE DETACHABLE COIL SYSTEM
K
03
0963
TRUFILL DCS ORBIT DETACHABLE COIL AND TRUFILL DCS SYRINGE, ALSO KNOWN AS THE TRUFILL DCS ORBIT DETACHABLE COIL SYSTEM
K
03
1168
MATRIX STRETCH RESISTANT DETACHABLE COIL
K
03
0475
GDC STRETCH RESISTANT DETACHABLE COIL
K
02
3089
GELSPHERES EMBOLIC AGENT
K
02
2420
MICRUS STRETCH-RESISTANT MICROCOIL SYSTEM, MSR01
K
02
2735
MICROPLEX COIL SYSTEM (MCS) AND HYDROCOIL EMBOLIC SYSTEM (HES) WITH THE HYDROLINK SYRINGE KIT
K
02
2427
CONTOUR SE MICROSPHERES
K
02
0434
MICROPLEX COIL SYSTEM (MCS)
K
02
1914
MICROPLEX COIL SYSTEMS (MCS)
K
02
1494
GDC POWER SUPPLY, MODEL GDC POWER SUPPLY: 451007-4
K
02
0033
MAXISTAT PVA FOAM EMBOLIZATION PARTICLES
K
01
4041
TRUFILL DCS DETACHABLE COIL AND FRUFILL DCS SYRINGE, ALSO KNOWN AS THE TRUFILL DCS DETACHABLE COIL SYSTEM
K
01
2985
MATRIX DETACHABLE COILS
K
01
2145
MICROPLEX COIL SYSTEM
K
01
0026
EMBOGOLD MICROSPHERE
K
00
1678
PVA FOAM EMBOLIZATION PARTICLES
K
00
2056
MICRUS MICROCOIL DELIVERY SYSTEM, MDS03
K
00
0651
DETACH 18 AND DETACH 11, NEUROLOGICAL EMBOLIZATION COIL SYSTEM
K
00
2181
GDC ULTRASOFT COIL
K
00
1083
GUGLIELMI DETACHABLE COIL AND POWER SUPPLY, MODELS POWER SUPPLY : 451006-4; CABLES: 451102-4
K
99
1549
EMBOSPHERE MICROSPHERES
K
99
3415
GDC-10 STRETCH RESISTANT GUGLIELMI DETACHABLE COIL, GDC-10 2-DIAMETER STRETCH RESISTANT GUGLIELMI DETACHABLE COIL, GDC-1
K
99
3417
GDC-10 GUGLIELMI DETACHABLE COIL (GDC) (3D SHAPE GDC), GDC-18 GUGLIELMI DETACHABLE COIL (GDC) (3D SHAPE GDC)
K
99
3418
FIBERED GDC-18 VORTX SHAPE GUGLIELMI DETACHABLE COIL
K
99
1139
GUGLIELMI DETACHABLE (GDC)
K
98
3483
VASCULAR OCCLUSION SYSTEM
K
97
2881
CES VASCULAR OCCLUSION SYSTEM
K
96
4021
INTRAMED SIDE BRANCH OCCLUSION (SBO) SYSTEM (700095 AND 700099)
K
96
5174
TRUFILL PVA PARTICLES
K
96
4367
CES VASCULAR OCCLUSION SYSTEM
K
96
3307
GDC PATIENT RETURN ELECTTRODE MODEL 45021
K
96
2503
GUGLIELMI DETACHABLE COIL
K
96
1923
BERENSTEIN COIL
K
96
0705
GUGLIELMI DETACHABLE COIL
K
95
1256
DETACHABLE PLATINUM COIL (GUGLIELMI DETACHABLE COIL, GDC)
K
95
1314
TRUEFILL PVA PARTICLES
K
94
4354
CONTOUR EMBOLI
K
91
3556
IVALON EMBOLIZATION PARTICLES
K
91
4866
ITC CONTOUR EMBOLI, MODIFICATION
K
92
5876
ITC BUNJI PLATINUM EMBOLIZATION COIL
K
92
5523
ITC BUNJI PLATINUM EMBOLIZATION COIL
K
92
0324
ITC BUNJI COIL (MODIFICATION)
K
91
3312
HELIX SHAPED COILS WITH DACRON FIBERS, MODIFIED
K
91
1779
HELIX SHAPED COILS WITH DACRON FIBERS, MODIFIED
K
90
0723
ITC BUNJI COIL
K
90
1337
HILAL EMBOLIZATION MICROCOIL(TM)
K
90
1721
MODIFIED TARGET THERAPEUTICS COILS
K
89
1688
COIL AND COIL DELIVERY SYSTEM
K
87
1047
RADIOPAQUE SPHERICAL EMBOLI (RSE)
HCH
Clip, Aneurysm
JXG
Shunt, Central Nervous System And Components
JXH
Methyl Methacrylate For Aneurysmorrhaphy
JXI
Cuff, Nerve
JXK
Cranial Electrotherapy Stimulator To Treat Depression
JXL
Block, Bite
LEL
Device, Sleep Assessment
LHG
Electrode, Spinal Epidural
LIH
Interferential Current Therapy
MVA
Orthosis, Cranial
MYU
Accessory, Barium Sulfate, Methyl Methacrylate For Cranioplasty
MZQ
Balloon, Detachable, For Neurovascular Occlusion
NFO
Stimulator, Transcutaneous Electrical, Aesthetic Purposes
NHI
Stimulator, Nerve, Electrical, Percutaneous (Pens), For Pain Relief
NUF
Catheter, Neurovasculature, Occluding Balloon
NUH
Stimulator, Nerve, Transcutaneous, Over-The-Counter
NYN
Stimulator, Electrical, Transcutaneous, For Arthritis
NYW
Stimulator, Nerve, Electrical, Transcutaneous, With Limited Output, For Pain Relief
NYX
Stimulator, Electrical, Transcutaneous, With Limited Output, For Aesthetic Purposes
OAN
Orthosis, Cranial, Laser Scan
OBP
Transcranial Magnetic Stimulator
OBV
Eating Disorder Conditioning Tool
OCF
Stimulator, Nerve, Electrical, Transcutaneous, Limited Output, Arthritis Pain Relief
OKP
Transcranial Magnetic Stimulator For The Treatment Of Migraine Headache
QMD
Transcranial Magnetic Stimulation System For Smoking Cessation
OSG
Piezo-Electric Stimulator For Relief Of Mosquito Bite Itch
PAV
Catheter, Neuro-Vasculature, Occluding Balloon
PBJ
Cranial Distraction System
PCB
External Cerebrospinal Fluid (Csf) Diversion
PCC
Stimulator, Nerve, Electrical, Transcutaneous, For Migraine
PJM
Filler, Bone Void, Alterable Compound For Cranioplasty
PJN
Filler, Bone Void, Non-Alterable Compound For Cranioplasty
PKR
Non-Invasive Vagus Nerve Stimulator - Headache
PLU
Thermal System For Insomnia
POL
Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment
PUU
Temporary Coil Embolization Assist Device
PVL
Endoscopic Shunt Placement Kit
PVO
Lumbar Drainage Catheter Kit
PWE
Computerized Behavioral Therapy Device For Psychiatric Disorders
PZR
Percutaneous Nerve Stimulator For Opioid Withdrawal
QAK
Non-Invasive Vagus Nerve Stimulator For Migraine Headache
QAR
Thermal Vestibular Stimulator For Headache
QBC
External Upper Limb Tremor Stimulator
QCI
Transcranial Magnetic Stimulation System For Obsessive-Compulsive Disorder
QFD
Tens For Sinus Pain
QFF
Electromechanical Arm For A Transcranial Magnetic Stimulation System
QGH
Electroconvulsive Therapy Device For Catatonia, Major Depressive Disorder, And Bipolar Disorder
QGL
Transcutaneous Nerve Stimulator For Adhd
QGT
Distal Transcutaneous Electrical Stimulator For Treatment Of Acute Migraine
QJQ
Cranial Electrotherapy Stimulator To Treat Insomnia And/Or Anxiety
QMZ
Digital Therapy Device To Reduce Sleep Disturbance For Psychiatric Conditions
QQC
Brain Stimulation Programming Planning Software.
QFT
Digital Therapeutic Software For Attention Deficit Hyperactivity Disorder
OVP
Vibratory Counter-Stimulation
QVO
Computerized Behavioral Therapy Device For Insomnia
SAP
Computerized Behavioral Therapy Device For Depressive Disorders.
SCP
Computerized Behavioral Therapy Device For Anxiety Disorders
Subpart F—Physical Medicine Therapeutic Devices
Subpart F—Therapeutic Devices
Obstetrical and Gynecological
Ophthalmic
Orthopedic
Pathology
Physical Medicine
Radiology
General and Plastic Surgery
Toxicology
Medical Genetics
Unknown
NE
/
subpart-f—neurological-therapeutic-devices
/
HCG
/
K033761
View Source
GELSPHERES / BEADBLOCK COMPRESSIBLE MICROSPHERES
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K033761
510(k) Type
Traditional
Applicant
BIOCOMPATIBLES U.K. LIMITED
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
2/4/2004
Days to Decision
64 days
Submission Type
Summary