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Innolitics
Anesthesiology
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Review Panel
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Review Panel
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Review Panel
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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
K
23
3801
Nalu Neurostimulation System for Spinal Cord Stimulation; Nalu Neurostimulation System for Peripheral Nerve Stimulation
2
Cleared 510(K)
K
22
1376
Nalu Neurostimulation System
2
Cleared 510(K)
K
20
3547
Nalu Neurostimulation System
2
Cleared 510(K)
K
20
2274
Nalu Neurostimulation Kit (lnte:gmted 40 em: Single 8/Dual 8), Nalu Neurostimulation Kit (Ported, 2 em: Single 8/Dual8), Dual 8 Ported Nalu Implantable Pulse Generator with 40 ern Kil, 40 cm/ 60 cm/60 em TrialJExtension Lead Kits, Patient Kits and miscellaneous replacement kits
2
Cleared 510(K)
K
20
1618
Nalu Neurostimulation SCS system
2
Cleared 510(K)
K
19
1466
SandShark Injectable Anchor (SIA) System
2
Cleared 510(K)
K
19
0960
Nalu Lead Blank (50cm)
2
Cleared 510(K)
K
18
2720
Freedom Spinal Cord Stimulator (SCS) System
2
Cleared 510(K)
K
18
3047
Nalu Neurostimulation System
2
Cleared 510(K)
K
18
0981
Stimulator Kit, Trial Kit, Spare Lead Kit, Wearable Assembly Kit
2
Cleared 510(K)
K
17
2644
Sandshark Injectable Anchor Kit, Injectroducer Handle, Loading Rod with Anchor, Loading Base
2
Cleared 510(K)
K
17
0141
Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, Wearable Antenna Assembly Kit and Charger Kit
2
Cleared 510(K)
K
16
2161
Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, Wearable Antenna Assembly Kit and Charger Kit
2
Cleared 510(K)
K
16
0600
Freedom Spinal Cord Stimulator System
2
Cleared 510(K)
K
15
0924
A.I.M. Lead Loop Suturing Device (1), A.I.M. Tension Assist/Suture Cutter Device, A.I.M. Lead Loop Suturing Device (1) plus Tension Assist/Suture Cutter Device, A.I.M. Lead Loop Suturing Device (2), A.I.M. Lead Loop Suturing Device plus Tension Assist/Suture Cutter Device
2
Cleared 510(K)
K
15
0517
Freedom Spinal Cord Stimulator System
2
Cleared 510(K)
K
14
1399
FREEDOM SPINAL CORD STIMULATOR (SCS) SYSTEM
2
Cleared 510(K)
K
14
0272
SWIFT-LOCK ANCHOR
2
Cleared 510(K)
K
13
0545
MULTI LEAD TRIAL CABLE
2
Cleared 510(K)
K
12
3299
MTS SYSTEM, WIDE-SPACE QUATTRODE PERCUTANEOUS LEADS
2
Cleared 510(K)
K
11
3611
RAPID PROGRAMMER
2
Cleared 510(K)
K
11
3805
FIXATE TISSUE BAND
2
Cleared 510(K)
K
11
3400
FIXATE TISSUE BAND
2
Cleared 510(K)
K
11
2214
OCTRODEX(TM), QUATTRODEX(TM), INTRODEX(TM), EPIDURAL NEEDLE, STYLETS
2
Cleared 510(K)
K
11
2849
FIXATE TISSUE BAND
2
Cleared 510(K)
K
11
1462
FIXATE TISSUE BAND
2
Cleared 510(K)
K
10
2523
MULTI-LEAD TRIALING CABLE MODEL 355531
2
Cleared 510(K)
K
09
2371
SWIFT-LOCK ANCHOR, MODEL 1192
2
Cleared 510(K)
K
09
1993
RAPID PROGRAMMER, VERSION 3.3.0
2
Cleared 510(K)
K
09
0907
PENTA LEAD KITS, MODELS: 3227-3234
2
Cleared 510(K)
K
08
1208
CINCH ANCHOR, MODEL 1194
2
Cleared 510(K)
K
07
2462
WIDE SPACED QUATTRODE LEADS
2
Cleared 510(K)
K
07
0847
TRIAL CABLE, 3009
2
Cleared 510(K)
K
06
3080
TRIPOLE 8C AND 16C AND EXCLAIM 8 LAMITRODE SERIES LEADS
2
Cleared 510(K)
K
06
2041
MODEL 3875 1 X 8 SC TEST STIMULATION LEAD
2
Cleared 510(K)
K
05
3250
ANS 90 CM AND 110 CM (3100 AND 3200 SERIES) LEAD KIT
2
Cleared 510(K)
K
05
2374
RAPID PROGEAMMER 3.0
2
Cleared 510(K)
K
05
2418
AXXESS BUTTERFLY ANCHOR
2
Cleared 510(K)
K
05
1773
MODEL 3873 1* 8 AND MODEL 3874 1* 8 COMPACT TEST STIMULATION LEADS
2
Cleared 510(K)
K
05
0922
ANS SCS ACCESSORY KIT
2
Cleared 510(K)
K
05
0633
TRIAL CABLE RETENTION CLIP
2
Cleared 510(K)
K
04
0609
RAPID PROGRAMMER
2
Cleared 510(K)
K
04
0568
POLYETHER URETHANE MATERIAL CHANGE IN NEUROSTIMULATION LEADS
2
Cleared 510(K)
K
03
3757
MTS MULTIPROGRAM TRIAL STIMULATOR SYSTEM
2
Cleared 510(K)
K
03
3429
LAMITRODE SPINAL CORD STIMULATION LEADS
2
Cleared 510(K)
K
03
3016
PISCES Z QUAD LEAD MODEL, 3890, PISCES Z QUAD COMPACT LEAD MODEL, 3891, PISCES Z QUAD PLUS LEAD MODEL, 3892
2
Cleared 510(K)
K
03
2751
MODIFICATION TO RENEW LEAD EXTENSION
2
Cleared 510(K)
K
03
2034
ANS AXXESS PERCUTANEOUS LEAD
2
Cleared 510(K)
K
03
2349
PLACER
2
Cleared 510(K)
K
03
2561
RESUME II LEAD KIT FOR SPINAL CORD STIMULATION (SCS) AND PERIPHERAL NERVE STIMULATION (PNS), RESUME TL LEAD KIT FOR
2
Cleared 510(K)
K
03
0461
A127 LEAD EXTENSION
2
Cleared 510(K)
K
03
0674
MODIFICATION TO AXXESS SPINAL CORD STIMULATION LEAD
2
Cleared 510(K)
K
03
0118
RAPID PROGRAMMAR
2
Cleared 510(K)
K
02
2222
LAMITRODE S-SERIES (S4 AND S8) LEADS
2
Cleared 510(K)
K
02
1518
PAINDOC
2
Cleared 510(K)
K
01
3120
PERCUTANEOUS INTRODUCER SET, MODEL 042294 AND KIT MODEL 3550-18
2
Cleared 510(K)
K
01
3063
GRIP LOCK ANCHOR, MODEL 411374
2
Cleared 510(K)
K
01
0300
MEDTRONIC MODEL 7495LZ LOW IMPEDANCE EXTENSION
2
Cleared 510(K)
K
01
0008
AXXESS SPINAL CORD STIMULATION LEAD, MODEL 8000 SERIES, INCLUDING 80XX, 81XX, AND 82XX
2
Cleared 510(K)
K
01
1584
MEDTRONIC SPINAL CORD STIMULATION AND PERIPHERAL NERVE STIMULATION SYSTEMS FOR PAIN RELIEF
2
Cleared 510(K)
K
00
0445
MEDTRONIC MODEL 7499 EXTENSION
2
Cleared 510(K)
K
99
4097
MEDAMICUS EPIDURAL INTRODUCER
2
Cleared 510(K)
K
99
2946
RENEW RECEIVER
2
Cleared 510(K)
K
99
1784
RENEW LEAD EXTENSION
2
Cleared 510(K)
K
99
0469
LAMITRODE LEADS
2
Cleared 510(K)
K
99
0104
MEDTRONIC MODEL 7495 EXTENSION KIT
2
Cleared 510(K)
K
97
2906
MEDTRONIC TWIST LOCK ANCHOR (PARTNUMBER 103953/3550TLA)
2
Cleared 510(K)
K
97
1756
MEDTRONIC MODEL 3998 LEAD
2
Cleared 510(K)
K
97
2043
MEDTRONIC MODEL 3273/3274 RF RECEIVER AND MODEL 3629/3630 SCREENER
2
Cleared 510(K)
K
96
4172
MEDTRONIC MODEL 3991A, 3992A, 3993A, 3994A LEADS OR TRANSVERSE TRIPOLAR LEADS OR TTL
2
Cleared 510(K)
K
95
3742
BIFURCATED Y-EXTENSION
2
Cleared 510(K)
K
96
0728
ONE STEP CONNECT LEADS (QUATTRODE, OCTRODE, CERVITRODE)
2
Cleared 510(K)
K
95
5291
DUALSCREEN
2
Cleared 510(K)
K
95
4886
MODEL NOS. 7495 AND 501826 EXTENSIONS
2
Cleared 510(K)
K
94
1342
PAIN DOC
2
Cleared 510(K)
K
95
2459
MEDTRONIC MODEL 3991, 3991C, 3992, 3992C, 3993, 3993C, 3994, 3994C LEADS OR, TRANSVERSE TRIPOLAR LEADS OR, TTL
2
Cleared 510(K)
K
94
3537
MODEL 3470 X-TREL RF RECEIVER
2
Cleared 510(K)
K
93
4065
MEDTRONIC MATTRIX 3271/3272 NEUROSTIMULATION SYSTEM
2
Cleared 510(K)
K
95
0127
ALTERNATE 100% ETO STERILIZATION PROCESS AND ALTERNATE STERILIZATION FACCILITY
2
Cleared 510(K)
K
94
5103
TEMP AND PERMANENT NEURO LEADS (VARIOUS MODELS)
2
Cleared 510(K)
K
93
0536
NEUROMED OCTRODE MODEL MNR-88A-B-C NEUROSTIM REC
2
Cleared 510(K)
K
93
0498
NEUROMED OCTRODE MODEL MNT-98 NEUROSTIMULATOR TRAN
2
Cleared 510(K)
K
94
0416
NEUROLOGICAL LEADS (PACKAGING MODIFICATION)
2
Cleared 510(K)
K
93
6099
NEUROLOGICAL LEAD ACCESSORIES
2
Cleared 510(K)
K
93
4938
TEMPORARY SCREENING LEAD/CATHETER KIT
2
Cleared 510(K)
K
93
2202
MODEL 3862A & B 3863A & B TEMP. LEAD SCREENING KIT
2
Cleared 510(K)
K
93
2948
MEDTRONIC MODEL 3625 SCREENER SYSTEM
2
Cleared 510(K)
K
93
0242
INTRODE INT-8
2
Cleared 510(K)
K
92
1319
NEUROMED MODEL OCA-30 OCTODE AND MODEL SCA-30
2
Cleared 510(K)
K
92
4522
MEDTRONIC MODEL 3080 PISCES-QUAD LEAD
2
Cleared 510(K)
K
92
3931
MEDTRONIC MODEL 3487A PISCES-QUAD LEAD
2
Cleared 510(K)
K
92
3567
MEDTRONIC MODEL 3888 PISCES-QUAD PLUS LEAD
2
Cleared 510(K)
K
92
1558
MEDTRONIC MODELS 3983A AND 3983B RESUME LEADS
2
Cleared 510(K)
K
91
3993
MEDTRONIC MODELS 3982 A,B,C&D STAG ARRAY RES LEADS
2
Cleared 510(K)
K
91
3934
MEDTRONIC MODEL 3586 RESUME LEAD
2
Cleared 510(K)
K
91
4433
MEDTRONIC MDLS 3487/3487A/3587/3587A SCS LEADS
2
Cleared 510(K)
K
91
3442
MEDTRONIC 3625 SCREENER SYSTEM
2
Cleared 510(K)
K
91
2764
MEDTRONIC MODEL 3861 TEMPORARY SCREENING LEAD KIT
2
Cleared 510(K)
K
90
5569
ELECTRO-NERVE STIMULATOR TENS,MODEL SYSTEMS PLUS/A
2
Cleared 510(K)
K
90
5596
NEUROMED OCTRODE MODEL MNR-88B/88C NEUROSTIM SYST
2
Cleared 510(K)
K
90
5402
ANTIGENZ CHLAMYDIA
2
Cleared 510(K)
K
90
3690
MEDTRONIC (R) MODEL 3625 SCREENER
2
Cleared 510(K)
K
91
0199
MEDTRONIC MODEL 3487A PISCES-QUAD LEAD
2
Cleared 510(K)
K
90
5407
MODEL 3487A PISCES-QUAD,3587A RESUME,3586 RESUME
2
Cleared 510(K)
K
90
5255
NEUROMED MODEL 1992 LS LAMITRODE LEAD
2
Cleared 510(K)
K
90
3814
NEUROMED TS8 TEST STIMULATOR
2
Cleared 510(K)
K
90
1499
NEUROMED OCTRODE MODEL MNR-88 W/98 ADAPTER NEURO.
2
Cleared 510(K)
K
89
0061
MODEL 3586 RESUME LEAD
2
Cleared 510(K)
K
89
2884
MEDTRONIC MODEL 3530 PERCUTANEOUS EXTENSION
2
Cleared 510(K)
K
88
5033
MODEL 3487A PISCES EPIDURAL LEAD
2
Cleared 510(K)
K
88
4948
MODEL 3587A RESUME EPIDURAL LEAD
2
Cleared 510(K)
K
88
3780
XTREL, MODEL NUMBER 3425
2
Cleared 510(K)
K
88
1491
MODEL 3487A PISCES EPIDURAL LEAD
2
Cleared 510(K)
K
87
3675
MODIFIED #3587 RESUME SE-4/#3487 PISCES-QUAD
2
Cleared 510(K)
K
86
2915
MULTISTIM(4-CHANNEL), MULTISTIM-OCTRODE(8 CHANNEL)
2
Cleared 510(K)
K
85
5107
MEDTRONIC MODEL 3422A TRANSMITTER ANTENNA KIT
2
Cleared 510(K)
K
86
0185
UNISTIM UNT-1M NEUROSTIMULATOR TRANSMITTER
2
Cleared 510(K)
K
86
0158
8-CHANNEL MULTIPROG IMPLANT SPINAL CORD STIMULATOR
2
Cleared 510(K)
K
85
3643
MULTISTIM LAMINECTOMY ELECTRODE
2
Cleared 510(K)
K
85
2326
UNISTIM UNT-1
2
Cleared 510(K)
K
85
2920
QUADRA CATH ELECT(3MM SIZES) 1990J, JF, JP + JPF
2
Cleared 510(K)
K
85
2827
CORDIS EXTERNAL NEURAL STIMULATOR MODEL 911A
2
Cleared 510(K)
K
84
4115
MEDTRONIC 3465 SE-4F RECEIVER/EXTENSION FOR SPINAL
2
Cleared 510(K)
K
84
1584
MEDTRONIC RESUME SE-4 3587-LEAD-SPINAL
2
Cleared 510(K)
K
83
3990
SPINAL CORD STIMULATION SYS SE-4
2
Cleared 510(K)
K
83
3809
NEURAL STIMULATOR MONITOR
2
Cleared 510(K)
K
83
1746
PISCES #3487 EPIDURAL LEAD FOR SPINAL
2
Cleared 510(K)
K
82
3530
STIMUCORD EXTERNAL NEURAL STIM. 911A
2
Cleared 510(K)
K
82
0988
MEDTRONIC #1992-2 DUAL RATE TRANSMITTER
2
Cleared 510(K)
K
81
2155
MEDTRONIC DUAL CHANNEL SPINAL CORD STIM
2
Cleared 510(K)
K
81
2154
MEDTRONIC #3484 PISCES EPIDURAL LEAD
2
Cleared 510(K)
K
81
1655
MYELOSTAT DORSAL CORD STIMULATOR
2
Cleared 510(K)
K
81
0182
PROGRAMMABLE SPINAL CORAL STIM. SYSTEM
2
Cleared 510(K)
K
81
0319
CORDIS STIMUCORD EXTERNAL NEUTRAL STIM
2
Cleared 510(K)
K
80
1384
MYELOSTAT DORSAL CORD STIMULATOR, ETC.
2
Cleared 510(K)
K
80
0193
MEDTRONIC PISCES GENERATION II LEAD KIT
2
Cleared 510(K)
K
79
0790
PISCES-SELECTOR X
2
Cleared 510(K)
K
78
0758
NEUROLOGICAL SCREENING STIMULATOR M 3623
2
Cleared 510(K)
K
78
0001
EPIDURAL LEAD - MODEL 3481
2
Cleared 510(K)
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
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
Review Panel
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 6 December 2024 at 11:05 pm
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subpart-f—neurological-therapeutic-devices
/
GZB
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K052418
View Source
AXXESS BUTTERFLY ANCHOR
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K052418
510(k) Type
Special
Applicant
ADVANCED NEUROMODULATION SYSTEMS
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
9/26/2005
Days to Decision
24 days
Submission Type
Statement
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)
K
23
3801
Nalu Neurostimulation System for Spinal Cord Stimulation; Nalu Neurostimulation System for Peripheral Nerve Stimulation
K
22
1376
Nalu Neurostimulation System
K
20
3547
Nalu Neurostimulation System
K
20
2274
Nalu Neurostimulation Kit (lnte:gmted 40 em: Single 8/Dual 8), Nalu Neurostimulation Kit (Ported, 2 em: Single 8/Dual8), Dual 8 Ported Nalu Implantable Pulse Generator with 40 ern Kil, 40 cm/ 60 cm/60 em TrialJExtension Lead Kits, Patient Kits and miscellaneous replacement kits
K
20
1618
Nalu Neurostimulation SCS system
K
19
1466
SandShark Injectable Anchor (SIA) System
K
19
0960
Nalu Lead Blank (50cm)
K
18
2720
Freedom Spinal Cord Stimulator (SCS) System
K
18
3047
Nalu Neurostimulation System
K
18
0981
Stimulator Kit, Trial Kit, Spare Lead Kit, Wearable Assembly Kit
K
17
2644
Sandshark Injectable Anchor Kit, Injectroducer Handle, Loading Rod with Anchor, Loading Base
K
17
0141
Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, Wearable Antenna Assembly Kit and Charger Kit
K
16
2161
Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, Wearable Antenna Assembly Kit and Charger Kit
K
16
0600
Freedom Spinal Cord Stimulator System
K
15
0924
A.I.M. Lead Loop Suturing Device (1), A.I.M. Tension Assist/Suture Cutter Device, A.I.M. Lead Loop Suturing Device (1) plus Tension Assist/Suture Cutter Device, A.I.M. Lead Loop Suturing Device (2), A.I.M. Lead Loop Suturing Device plus Tension Assist/Suture Cutter Device
K
15
0517
Freedom Spinal Cord Stimulator System
K
14
1399
FREEDOM SPINAL CORD STIMULATOR (SCS) SYSTEM
K
14
0272
SWIFT-LOCK ANCHOR
K
13
0545
MULTI LEAD TRIAL CABLE
K
12
3299
MTS SYSTEM, WIDE-SPACE QUATTRODE PERCUTANEOUS LEADS
K
11
3611
RAPID PROGRAMMER
K
11
3805
FIXATE TISSUE BAND
K
11
3400
FIXATE TISSUE BAND
K
11
2214
OCTRODEX(TM), QUATTRODEX(TM), INTRODEX(TM), EPIDURAL NEEDLE, STYLETS
K
11
2849
FIXATE TISSUE BAND
K
11
1462
FIXATE TISSUE BAND
K
10
2523
MULTI-LEAD TRIALING CABLE MODEL 355531
K
09
2371
SWIFT-LOCK ANCHOR, MODEL 1192
K
09
1993
RAPID PROGRAMMER, VERSION 3.3.0
K
09
0907
PENTA LEAD KITS, MODELS: 3227-3234
K
08
1208
CINCH ANCHOR, MODEL 1194
K
07
2462
WIDE SPACED QUATTRODE LEADS
K
07
0847
TRIAL CABLE, 3009
K
06
3080
TRIPOLE 8C AND 16C AND EXCLAIM 8 LAMITRODE SERIES LEADS
K
06
2041
MODEL 3875 1 X 8 SC TEST STIMULATION LEAD
K
05
3250
ANS 90 CM AND 110 CM (3100 AND 3200 SERIES) LEAD KIT
K
05
2374
RAPID PROGEAMMER 3.0
K
05
2418
AXXESS BUTTERFLY ANCHOR
K
05
1773
MODEL 3873 1* 8 AND MODEL 3874 1* 8 COMPACT TEST STIMULATION LEADS
K
05
0922
ANS SCS ACCESSORY KIT
K
05
0633
TRIAL CABLE RETENTION CLIP
K
04
0609
RAPID PROGRAMMER
K
04
0568
POLYETHER URETHANE MATERIAL CHANGE IN NEUROSTIMULATION LEADS
K
03
3757
MTS MULTIPROGRAM TRIAL STIMULATOR SYSTEM
K
03
3429
LAMITRODE SPINAL CORD STIMULATION LEADS
K
03
3016
PISCES Z QUAD LEAD MODEL, 3890, PISCES Z QUAD COMPACT LEAD MODEL, 3891, PISCES Z QUAD PLUS LEAD MODEL, 3892
K
03
2751
MODIFICATION TO RENEW LEAD EXTENSION
K
03
2034
ANS AXXESS PERCUTANEOUS LEAD
K
03
2349
PLACER
K
03
2561
RESUME II LEAD KIT FOR SPINAL CORD STIMULATION (SCS) AND PERIPHERAL NERVE STIMULATION (PNS), RESUME TL LEAD KIT FOR
K
03
0461
A127 LEAD EXTENSION
K
03
0674
MODIFICATION TO AXXESS SPINAL CORD STIMULATION LEAD
K
03
0118
RAPID PROGRAMMAR
K
02
2222
LAMITRODE S-SERIES (S4 AND S8) LEADS
K
02
1518
PAINDOC
K
01
3120
PERCUTANEOUS INTRODUCER SET, MODEL 042294 AND KIT MODEL 3550-18
K
01
3063
GRIP LOCK ANCHOR, MODEL 411374
K
01
0300
MEDTRONIC MODEL 7495LZ LOW IMPEDANCE EXTENSION
K
01
0008
AXXESS SPINAL CORD STIMULATION LEAD, MODEL 8000 SERIES, INCLUDING 80XX, 81XX, AND 82XX
K
01
1584
MEDTRONIC SPINAL CORD STIMULATION AND PERIPHERAL NERVE STIMULATION SYSTEMS FOR PAIN RELIEF
K
00
0445
MEDTRONIC MODEL 7499 EXTENSION
K
99
4097
MEDAMICUS EPIDURAL INTRODUCER
K
99
2946
RENEW RECEIVER
K
99
1784
RENEW LEAD EXTENSION
K
99
0469
LAMITRODE LEADS
K
99
0104
MEDTRONIC MODEL 7495 EXTENSION KIT
K
97
2906
MEDTRONIC TWIST LOCK ANCHOR (PARTNUMBER 103953/3550TLA)
K
97
1756
MEDTRONIC MODEL 3998 LEAD
K
97
2043
MEDTRONIC MODEL 3273/3274 RF RECEIVER AND MODEL 3629/3630 SCREENER
K
96
4172
MEDTRONIC MODEL 3991A, 3992A, 3993A, 3994A LEADS OR TRANSVERSE TRIPOLAR LEADS OR TTL
K
95
3742
BIFURCATED Y-EXTENSION
K
96
0728
ONE STEP CONNECT LEADS (QUATTRODE, OCTRODE, CERVITRODE)
K
95
5291
DUALSCREEN
K
95
4886
MODEL NOS. 7495 AND 501826 EXTENSIONS
K
94
1342
PAIN DOC
K
95
2459
MEDTRONIC MODEL 3991, 3991C, 3992, 3992C, 3993, 3993C, 3994, 3994C LEADS OR, TRANSVERSE TRIPOLAR LEADS OR, TTL
K
94
3537
MODEL 3470 X-TREL RF RECEIVER
K
93
4065
MEDTRONIC MATTRIX 3271/3272 NEUROSTIMULATION SYSTEM
K
95
0127
ALTERNATE 100% ETO STERILIZATION PROCESS AND ALTERNATE STERILIZATION FACCILITY
K
94
5103
TEMP AND PERMANENT NEURO LEADS (VARIOUS MODELS)
K
93
0536
NEUROMED OCTRODE MODEL MNR-88A-B-C NEUROSTIM REC
K
93
0498
NEUROMED OCTRODE MODEL MNT-98 NEUROSTIMULATOR TRAN
K
94
0416
NEUROLOGICAL LEADS (PACKAGING MODIFICATION)
K
93
6099
NEUROLOGICAL LEAD ACCESSORIES
K
93
4938
TEMPORARY SCREENING LEAD/CATHETER KIT
K
93
2202
MODEL 3862A & B 3863A & B TEMP. LEAD SCREENING KIT
K
93
2948
MEDTRONIC MODEL 3625 SCREENER SYSTEM
K
93
0242
INTRODE INT-8
K
92
1319
NEUROMED MODEL OCA-30 OCTODE AND MODEL SCA-30
K
92
4522
MEDTRONIC MODEL 3080 PISCES-QUAD LEAD
K
92
3931
MEDTRONIC MODEL 3487A PISCES-QUAD LEAD
K
92
3567
MEDTRONIC MODEL 3888 PISCES-QUAD PLUS LEAD
K
92
1558
MEDTRONIC MODELS 3983A AND 3983B RESUME LEADS
K
91
3993
MEDTRONIC MODELS 3982 A,B,C&D STAG ARRAY RES LEADS
K
91
3934
MEDTRONIC MODEL 3586 RESUME LEAD
K
91
4433
MEDTRONIC MDLS 3487/3487A/3587/3587A SCS LEADS
K
91
3442
MEDTRONIC 3625 SCREENER SYSTEM
K
91
2764
MEDTRONIC MODEL 3861 TEMPORARY SCREENING LEAD KIT
K
90
5569
ELECTRO-NERVE STIMULATOR TENS,MODEL SYSTEMS PLUS/A
K
90
5596
NEUROMED OCTRODE MODEL MNR-88B/88C NEUROSTIM SYST
K
90
5402
ANTIGENZ CHLAMYDIA
K
90
3690
MEDTRONIC (R) MODEL 3625 SCREENER
K
91
0199
MEDTRONIC MODEL 3487A PISCES-QUAD LEAD
K
90
5407
MODEL 3487A PISCES-QUAD,3587A RESUME,3586 RESUME
K
90
5255
NEUROMED MODEL 1992 LS LAMITRODE LEAD
K
90
3814
NEUROMED TS8 TEST STIMULATOR
K
90
1499
NEUROMED OCTRODE MODEL MNR-88 W/98 ADAPTER NEURO.
K
89
0061
MODEL 3586 RESUME LEAD
K
89
2884
MEDTRONIC MODEL 3530 PERCUTANEOUS EXTENSION
K
88
5033
MODEL 3487A PISCES EPIDURAL LEAD
K
88
4948
MODEL 3587A RESUME EPIDURAL LEAD
K
88
3780
XTREL, MODEL NUMBER 3425
K
88
1491
MODEL 3487A PISCES EPIDURAL LEAD
K
87
3675
MODIFIED #3587 RESUME SE-4/#3487 PISCES-QUAD
K
86
2915
MULTISTIM(4-CHANNEL), MULTISTIM-OCTRODE(8 CHANNEL)
K
85
5107
MEDTRONIC MODEL 3422A TRANSMITTER ANTENNA KIT
K
86
0185
UNISTIM UNT-1M NEUROSTIMULATOR TRANSMITTER
K
86
0158
8-CHANNEL MULTIPROG IMPLANT SPINAL CORD STIMULATOR
K
85
3643
MULTISTIM LAMINECTOMY ELECTRODE
K
85
2326
UNISTIM UNT-1
K
85
2920
QUADRA CATH ELECT(3MM SIZES) 1990J, JF, JP + JPF
K
85
2827
CORDIS EXTERNAL NEURAL STIMULATOR MODEL 911A
K
84
4115
MEDTRONIC 3465 SE-4F RECEIVER/EXTENSION FOR SPINAL
K
84
1584
MEDTRONIC RESUME SE-4 3587-LEAD-SPINAL
K
83
3990
SPINAL CORD STIMULATION SYS SE-4
K
83
3809
NEURAL STIMULATOR MONITOR
K
83
1746
PISCES #3487 EPIDURAL LEAD FOR SPINAL
K
82
3530
STIMUCORD EXTERNAL NEURAL STIM. 911A
K
82
0988
MEDTRONIC #1992-2 DUAL RATE TRANSMITTER
K
81
2155
MEDTRONIC DUAL CHANNEL SPINAL CORD STIM
K
81
2154
MEDTRONIC #3484 PISCES EPIDURAL LEAD
K
81
1655
MYELOSTAT DORSAL CORD STIMULATOR
K
81
0182
PROGRAMMABLE SPINAL CORAL STIM. SYSTEM
K
81
0319
CORDIS STIMUCORD EXTERNAL NEUTRAL STIM
K
80
1384
MYELOSTAT DORSAL CORD STIMULATOR, ETC.
K
80
0193
MEDTRONIC PISCES GENERATION II LEAD KIT
K
79
0790
PISCES-SELECTOR X
K
78
0758
NEUROLOGICAL SCREENING STIMULATOR M 3623
K
78
0001
EPIDURAL LEAD - MODEL 3481
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
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
/
GZB
/
K052418
View Source
AXXESS BUTTERFLY ANCHOR
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K052418
510(k) Type
Special
Applicant
ADVANCED NEUROMODULATION SYSTEMS
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
9/26/2005
Days to Decision
24 days
Submission Type
Statement