FDA Browser
by
Innolitics
Anesthesiology
Review Panel
Cardiovascular
Review Panel
Chemistry
Review Panel
Dental
Review Panel
Ear, Nose, Throat
Review Panel
Gastroenterology and Urology
Review Panel
General Hospital
Review Panel
Hematology
Review Panel
Immunology
Review Panel
Microbiology
Review Panel
Neurology
Review Panel
Miscellaneous
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
GXD
Generator, Lesion, Radiofrequency
2
Product Code
GXE
Leukotome
1
Product Code
GXH
Device, Surgical, Cryogenic
2
Product Code
GXI
Probe, Radiofrequency Lesion
2
Product Code
K
22
2281
Intracept Intraosseous Nerve Ablation System
2
Cleared 510(K)
K
21
3836
Intracept Intraosseous Nerve Ablation System
2
Cleared 510(K)
K
20
3066
COOLIEF Cooled Radiofrequency Kit Advanced
2
Cleared 510(K)
K
19
0259
Vesta RF Cannula
2
Cleared 510(K)
K
19
1293
LCCS VC-S RF Cannula
2
Cleared 510(K)
K
19
0504
Intracept Intraosseous Nerve Ablation System (RF Probe), Intracept Intraosseous Nerve Ablation System (Access Instruments), Relievant RF Generator
2
Cleared 510(K)
K
19
0256
Rulo Radiofrequency Lesion Probe
2
Cleared 510(K)
K
18
3177
Nitinol Thermocouple (TCN) Electrode
2
Cleared 510(K)
K
18
0369
Intracept Intraosseous Nerve Ablation System (component Intracept RF Probe)
2
Cleared 510(K)
K
17
0827
INTRACEPT Intraosseous Nerve Ablation System
2
Cleared 510(K)
K
17
0708
OWL RF INSULATED CANNULAE
2
Cleared 510(K)
K
16
3461
Coolief* Cooled RF Probe
2
Cleared 510(K)
K
16
3236
COOLIEF Cooled Radiofrequency Kit
2
Cleared 510(K)
K
15
2642
LCCS Disposable RF Electrode, LCCS Reusable RF Electrode
2
Cleared 510(K)
K
15
3272
INTRACEPT Flexible Bi-Polar RF Probe and Easy Access Instrument Set
2
Cleared 510(K)
K
15
0371
Diros OWL Sterile Single Use TridentTM R.F. Insulated Cannulae,Models DTR and DTRH
2
Cleared 510(K)
K
14
1586
OWL CANNULAE
2
Cleared 510(K)
K
12
3178
STRYKER VENOM ELECTRODES AND CANNULAE
2
Cleared 510(K)
K
12
1773
NIMBUS ELECTROSURGICAL RADIOFREQUENCY MULTITINED EXPANDABLE ELECTRODE
2
Cleared 510(K)
K
11
2231
LCCS INSULATED SPINAL NEEDLE (RF CANNULA)
2
Cleared 510(K)
K
10
2566
OWL CANNULAE
2
Cleared 510(K)
K
11
0593
OWL RF PROBES
2
Cleared 510(K)
K
10
1372
DUOCOOL PAIN MANAGEMENT PROBE, MODEL OSP-17-180-20
2
Cleared 510(K)
K
09
0608
MINTA RYAN RF THERMOCOUPLE ELECTRODE (RYAN-50, 100, 150 AND 200), MINTA INTERMEDIATE CABLE (RYAN-C, -R, -B)
2
Cleared 510(K)
K
09
2337
PAIN MANAGEMENT OPTIMA, MODEL PMO21-100-05, PMO20-100-10CS, PMO20-145-10CS
2
Cleared 510(K)
K
09
0955
SMITH & NEPHEW RF CANNULATE
2
Cleared 510(K)
K
08
0771
TOP NEUROPOLE NEEDLE, MODEL SH, BL, SC, TC
2
Cleared 510(K)
K
08
2012
COSMAN RF INJECTION ELECTRODES, MODELS CU, CUR, CCD, TCD, CP, CR, CN
2
Cleared 510(K)
K
07
1300
MODIFICATION TO SMITH & NEPHEW RF DENERVATION PROBES & RF CANNULAE
2
Cleared 510(K)
K
07
1745
BAYLIS PAIN MANAGEMENT SINGLE-USE PROBE
2
Cleared 510(K)
K
06
2946
TOP NEUROPOLE NEEDLES, MODELS ST, X, RC, XE AND TL
2
Cleared 510(K)
K
06
2937
TRANSDISCAL SYSTEM, MODELS TDP-17-150-6, TDI-17-150, TDA-PPU-1, TDA-TBK-1, TDX-Y-TSW-TDP, TDX-PMG-PPU
2
Cleared 510(K)
K
06
3467
SMITH & NEPHEW RF CANNULAE
2
Cleared 510(K)
K
06
0397
RF LESION CANNULA, RF THERMOLESION CANNULA, THERMOLESION CANNULA, X-RAY CONTRAST CANNULA, CANNULA, FACET DENERATION NEED
2
Cleared 510(K)
K
06
0799
COSMAN CSK RF CANNULA; COSMAN RFK RF CANNULA
2
Cleared 510(K)
K
05
3415
LESIONPOINT RF CANNULA
2
Cleared 510(K)
K
05
3082
BAYLIS PAIN MANAGEMENT COOLED PROBE, MODEL PMPC-18-150-6
2
Cleared 510(K)
K
04
3442
STRYKER RF COAXIAL BIPOLAR ELECTRODES & CANNULAE
2
Cleared 510(K)
K
05
0084
COSMAN RF LESION GENERATOR, MODEL RFG-1A; COSMAN TEW TRIGEMINAL ELECTRODE KIT; COSMAN TIC TRIGEMINAL ELECTRODE KIT;
2
Cleared 510(K)
K
04
2375
SMK, CX, CXE, RCN
2
Cleared 510(K)
K
04
1021
RF INTRODUCTION CANNULA
2
Cleared 510(K)
K
03
2406
STRYKER RF ELECTRODES AND CANNULAE
2
Cleared 510(K)
K
03
4012
SMITH & NEPHEW RF DENERVATION PROBES & RF CANNULAE
2
Cleared 510(K)
K
03
2196
NBD DISPOSABLE RF CANNULAE
2
Cleared 510(K)
K
02
1942
RADIONICS POLE NEEDLES
2
Cleared 510(K)
K
01
1387
NEUROTHERM, MODEL JK4
2
Cleared 510(K)
K
00
2389
BAYLIS PAIN MANAGEMENT PROBE/PMP-20-145 AND BAYLIS PAIN MANAGEMENT CONNECTOR CABLE/PMX-BAY-BAY
2
Cleared 510(K)
K
00
1588
ARTHROCARE SYSTEM 2000 CONTROLLER, ARTHROCARE SYSTEM 2000 CABLE, ARTHROCARE SYSTEM 2000 FOOTSWITCH, ARTHROCARE SYSTEM 20
2
Cleared 510(K)
K
99
4344
NEUROTHERM RF CANNULA
2
Cleared 510(K)
K
00
0073
MERCURY MEDICAL DISPOSABLE RADIOFREQUENCY CANNULA
2
Cleared 510(K)
K
99
1399
RADIONICS MICROELECTRODE KIT
2
Cleared 510(K)
K
97
2846
BMC RF CANNULA
2
Cleared 510(K)
K
98
0430
RADIONICS DISPOSABLE RF CANNULAE (SC-C, RFK-DB, RFK-DS)
2
Cleared 510(K)
K
88
4347
MODIFIED DISPOSABLE COAXIAL BIPOLAR PEN
2
Cleared 510(K)
K
88
2802
STORZ DISPOSABLE BIPOLAR PENCILS
2
Cleared 510(K)
K
88
0951
DISPOSABLE COAXIAL BIPOLAR PEN P/N 00150
2
Cleared 510(K)
K
88
0925
DISPOSABLE WET FIELD ERASER
2
Cleared 510(K)
K
88
0293
THE STORZ BIPOLAR PENCIL AND CORD
2
Cleared 510(K)
K
87
0028
SMK SLUYTER-MEHTA CANNULAE, RF POLE, POLE,FLEXIBLE
2
Cleared 510(K)
K
80
2243
VAXIOM FAMILY OF RF LESION PROBES & ELEC
2
Cleared 510(K)
GXJ
Punch, Skull
1
Product Code
GXL
Screwdriver, Skullplate
1
Product Code
GXM
Anvil, Skull Plate
1
Product Code
GYK
Instrument, Shunt System Implantation
1
Product Code
GZQ
Instrument, Dowel Cutting
2
Product Code
GZT
Retractor, Self-Retaining, For Neurosurgery
2
Product Code
GZX
Instrument, Microsurgical
1
Product Code
HAD
Rongeur, Powered
2
Product Code
HAE
Rongeur, Manual
2
Product Code
HAO
Instrument, Surgical, Non-Powered
1
Product Code
HAS
Needle, Neurosurgical Suture
1
Product Code
HAW
Neurological Stereotaxic Instrument
2
Product Code
HBA
Neurosurgical Paddie
2
Product Code
HBB
Motor, Drill, Pneumatic
2
Product Code
HBC
Motor, Drill, Electric
2
Product Code
HBD
Handpiece (Brace), Drill
1
Product Code
HBE
Drills, Burrs, Trephines & Accessories (Simple, Powered)
2
Product Code
HBF
Drills, Burrs, Trephines & Accessories (Compound, Powered)
2
Product Code
HBG
Drills, Burrs, Trephines & Accessories (Manual)
2
Product Code
HBL
Holder, Head, Neurosurgical (Skull Clamp)
2
Product Code
HBM
Headrest, Neurosurgical
1
Product Code
HBN
Chair, Neurosurgical
1
Product Code
HBO
Clip, Scalp
2
Product Code
HBQ
Instrument, Clip Removal
1
Product Code
HBR
Rack, Clip
1
Product Code
HBS
Instrument, Clip Forming/Cutting
1
Product Code
HBX
Instrument, Cranioplasty Material Forming
1
Product Code
HCA
Catheter, Ventricular
2
Product Code
HCD
Cannula, Ventricular
1
Product Code
HCI
Applier, Aneurysm Clip
2
Product Code
NHC
Catheter, Ventricular (Containing Antibiotic Or Antimicrobial Agents)
2
Product Code
NLN
Drills, Burrs, Trephines And Accessories (Simple Powered), Reprocessed
2
Product Code
NLO
Drills, Burrs, Trephines And Accessories (Manual), Reprocessed
2
Product Code
NLP
Drills, Burrs, Trephines, And Accessories (Powered Compound), Reprocessed
2
Product Code
NMN
Instrument, Clip, Forming/Cutting, Reprocessed
1
Product Code
OJG
Neurological Tray
1
Product Code
ORR
Neurological Stereotaxic Instrument, Real-Time Intraoperative Mri
2
Product Code
PIY
Stainless Steel Instrument, Shunt System Implantation
1
Product Code
PPT
Cranial Surgical Planning And Instrument Guides
2
Product Code
PVM
Endoscopic Ventricular Catheter Placement Kit
2
Product Code
QFX
Diagnostic Neurosurgical Microscope Filter
2
Product Code
QRI
Surgical Planning Software For Neurological Stereotaxic Instruments
2
Product Code
Subpart E—Surgical Devices
CFR Sub-Part
Subpart F—Cardiovascular Therapeutic Devices
CFR Sub-Part
Subpart F—Neurological Therapeutic Devices
CFR Sub-Part
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 16 August 2024 at 11:05 pm
NE
/
subpart-e—neurological-surgical-devices
/
GXI
/
K884347
View Source
MODIFIED DISPOSABLE COAXIAL BIPOLAR PEN
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K884347
510(k) Type
Traditional
Applicant
ADVANCED SURGICAL PRODUCTS, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
12/27/1988
Days to Decision
74 days
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
GXD
Generator, Lesion, Radiofrequency
GXE
Leukotome
GXH
Device, Surgical, Cryogenic
GXI
Probe, Radiofrequency Lesion
K
22
2281
Intracept Intraosseous Nerve Ablation System
K
21
3836
Intracept Intraosseous Nerve Ablation System
K
20
3066
COOLIEF Cooled Radiofrequency Kit Advanced
K
19
0259
Vesta RF Cannula
K
19
1293
LCCS VC-S RF Cannula
K
19
0504
Intracept Intraosseous Nerve Ablation System (RF Probe), Intracept Intraosseous Nerve Ablation System (Access Instruments), Relievant RF Generator
K
19
0256
Rulo Radiofrequency Lesion Probe
K
18
3177
Nitinol Thermocouple (TCN) Electrode
K
18
0369
Intracept Intraosseous Nerve Ablation System (component Intracept RF Probe)
K
17
0827
INTRACEPT Intraosseous Nerve Ablation System
K
17
0708
OWL RF INSULATED CANNULAE
K
16
3461
Coolief* Cooled RF Probe
K
16
3236
COOLIEF Cooled Radiofrequency Kit
K
15
2642
LCCS Disposable RF Electrode, LCCS Reusable RF Electrode
K
15
3272
INTRACEPT Flexible Bi-Polar RF Probe and Easy Access Instrument Set
K
15
0371
Diros OWL Sterile Single Use TridentTM R.F. Insulated Cannulae,Models DTR and DTRH
K
14
1586
OWL CANNULAE
K
12
3178
STRYKER VENOM ELECTRODES AND CANNULAE
K
12
1773
NIMBUS ELECTROSURGICAL RADIOFREQUENCY MULTITINED EXPANDABLE ELECTRODE
K
11
2231
LCCS INSULATED SPINAL NEEDLE (RF CANNULA)
K
10
2566
OWL CANNULAE
K
11
0593
OWL RF PROBES
K
10
1372
DUOCOOL PAIN MANAGEMENT PROBE, MODEL OSP-17-180-20
K
09
0608
MINTA RYAN RF THERMOCOUPLE ELECTRODE (RYAN-50, 100, 150 AND 200), MINTA INTERMEDIATE CABLE (RYAN-C, -R, -B)
K
09
2337
PAIN MANAGEMENT OPTIMA, MODEL PMO21-100-05, PMO20-100-10CS, PMO20-145-10CS
K
09
0955
SMITH & NEPHEW RF CANNULATE
K
08
0771
TOP NEUROPOLE NEEDLE, MODEL SH, BL, SC, TC
K
08
2012
COSMAN RF INJECTION ELECTRODES, MODELS CU, CUR, CCD, TCD, CP, CR, CN
K
07
1300
MODIFICATION TO SMITH & NEPHEW RF DENERVATION PROBES & RF CANNULAE
K
07
1745
BAYLIS PAIN MANAGEMENT SINGLE-USE PROBE
K
06
2946
TOP NEUROPOLE NEEDLES, MODELS ST, X, RC, XE AND TL
K
06
2937
TRANSDISCAL SYSTEM, MODELS TDP-17-150-6, TDI-17-150, TDA-PPU-1, TDA-TBK-1, TDX-Y-TSW-TDP, TDX-PMG-PPU
K
06
3467
SMITH & NEPHEW RF CANNULAE
K
06
0397
RF LESION CANNULA, RF THERMOLESION CANNULA, THERMOLESION CANNULA, X-RAY CONTRAST CANNULA, CANNULA, FACET DENERATION NEED
K
06
0799
COSMAN CSK RF CANNULA; COSMAN RFK RF CANNULA
K
05
3415
LESIONPOINT RF CANNULA
K
05
3082
BAYLIS PAIN MANAGEMENT COOLED PROBE, MODEL PMPC-18-150-6
K
04
3442
STRYKER RF COAXIAL BIPOLAR ELECTRODES & CANNULAE
K
05
0084
COSMAN RF LESION GENERATOR, MODEL RFG-1A; COSMAN TEW TRIGEMINAL ELECTRODE KIT; COSMAN TIC TRIGEMINAL ELECTRODE KIT;
K
04
2375
SMK, CX, CXE, RCN
K
04
1021
RF INTRODUCTION CANNULA
K
03
2406
STRYKER RF ELECTRODES AND CANNULAE
K
03
4012
SMITH & NEPHEW RF DENERVATION PROBES & RF CANNULAE
K
03
2196
NBD DISPOSABLE RF CANNULAE
K
02
1942
RADIONICS POLE NEEDLES
K
01
1387
NEUROTHERM, MODEL JK4
K
00
2389
BAYLIS PAIN MANAGEMENT PROBE/PMP-20-145 AND BAYLIS PAIN MANAGEMENT CONNECTOR CABLE/PMX-BAY-BAY
K
00
1588
ARTHROCARE SYSTEM 2000 CONTROLLER, ARTHROCARE SYSTEM 2000 CABLE, ARTHROCARE SYSTEM 2000 FOOTSWITCH, ARTHROCARE SYSTEM 20
K
99
4344
NEUROTHERM RF CANNULA
K
00
0073
MERCURY MEDICAL DISPOSABLE RADIOFREQUENCY CANNULA
K
99
1399
RADIONICS MICROELECTRODE KIT
K
97
2846
BMC RF CANNULA
K
98
0430
RADIONICS DISPOSABLE RF CANNULAE (SC-C, RFK-DB, RFK-DS)
K
88
4347
MODIFIED DISPOSABLE COAXIAL BIPOLAR PEN
K
88
2802
STORZ DISPOSABLE BIPOLAR PENCILS
K
88
0951
DISPOSABLE COAXIAL BIPOLAR PEN P/N 00150
K
88
0925
DISPOSABLE WET FIELD ERASER
K
88
0293
THE STORZ BIPOLAR PENCIL AND CORD
K
87
0028
SMK SLUYTER-MEHTA CANNULAE, RF POLE, POLE,FLEXIBLE
K
80
2243
VAXIOM FAMILY OF RF LESION PROBES & ELEC
GXJ
Punch, Skull
GXL
Screwdriver, Skullplate
GXM
Anvil, Skull Plate
GYK
Instrument, Shunt System Implantation
GZQ
Instrument, Dowel Cutting
GZT
Retractor, Self-Retaining, For Neurosurgery
GZX
Instrument, Microsurgical
HAD
Rongeur, Powered
HAE
Rongeur, Manual
HAO
Instrument, Surgical, Non-Powered
HAS
Needle, Neurosurgical Suture
HAW
Neurological Stereotaxic Instrument
HBA
Neurosurgical Paddie
HBB
Motor, Drill, Pneumatic
HBC
Motor, Drill, Electric
HBD
Handpiece (Brace), Drill
HBE
Drills, Burrs, Trephines & Accessories (Simple, Powered)
HBF
Drills, Burrs, Trephines & Accessories (Compound, Powered)
HBG
Drills, Burrs, Trephines & Accessories (Manual)
HBL
Holder, Head, Neurosurgical (Skull Clamp)
HBM
Headrest, Neurosurgical
HBN
Chair, Neurosurgical
HBO
Clip, Scalp
HBQ
Instrument, Clip Removal
HBR
Rack, Clip
HBS
Instrument, Clip Forming/Cutting
HBX
Instrument, Cranioplasty Material Forming
HCA
Catheter, Ventricular
HCD
Cannula, Ventricular
HCI
Applier, Aneurysm Clip
NHC
Catheter, Ventricular (Containing Antibiotic Or Antimicrobial Agents)
NLN
Drills, Burrs, Trephines And Accessories (Simple Powered), Reprocessed
NLO
Drills, Burrs, Trephines And Accessories (Manual), Reprocessed
NLP
Drills, Burrs, Trephines, And Accessories (Powered Compound), Reprocessed
NMN
Instrument, Clip, Forming/Cutting, Reprocessed
OJG
Neurological Tray
ORR
Neurological Stereotaxic Instrument, Real-Time Intraoperative Mri
PIY
Stainless Steel Instrument, Shunt System Implantation
PPT
Cranial Surgical Planning And Instrument Guides
PVM
Endoscopic Ventricular Catheter Placement Kit
QFX
Diagnostic Neurosurgical Microscope Filter
QRI
Surgical Planning Software For Neurological Stereotaxic Instruments
Subpart E—Surgical Devices
Subpart F—Cardiovascular Therapeutic Devices
Subpart F—Neurological Therapeutic Devices
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-e—neurological-surgical-devices
/
GXI
/
K884347
View Source
MODIFIED DISPOSABLE COAXIAL BIPOLAR PEN
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K884347
510(k) Type
Traditional
Applicant
ADVANCED SURGICAL PRODUCTS, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
12/27/1988
Days to Decision
74 days