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
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
K
22
0920
Matreneu Percutaneous Balloon Compression Kit
1
Cleared 510(K)
K
94
0973
MULLAN GANGLION MICROCOMPRESSION SET
1
Cleared 510(K)
K
95
1492
RIB RESECTOR
1
Cleared 510(K)
K
94
3115
AUTO SUTURE PITUITARY SPINAL RONGEUR
1
Cleared 510(K)
K
94
2969
AUTO SUTURE SPINAL NERVE HOOK
1
Cleared 510(K)
K
94
2968
AUTO SUTURE SPINAL OSTEOTOME
1
Cleared 510(K)
K
94
2970
AUTO SUTURE SPINAL ELEVATOR
1
Cleared 510(K)
K
94
2971
AUTO SUTURE SPINAL DISSECTOR
1
Cleared 510(K)
K
94
2967
AUTO SUTURE SPINAL CURETTE
1
Cleared 510(K)
K
92
3723
SILICONE BRAIN SPATULA SET
1
Cleared 510(K)
K
91
0226
DURAL DISSECTORS
1
Cleared 510(K)
K
91
0225
BONE PAD REMOVER
1
Cleared 510(K)
K
90
2850
ZEPPELIN INSTRUMENTS
1
Cleared 510(K)
K
89
2546
TAYLOR SPINAL RETRACTOR
1
Cleared 510(K)
K
88
2422
DISPOSABLE ARACHNOID KNIFE
1
Cleared 510(K)
K
88
0278
MALLEABLE PTFE COATED BRAIN SPATULAE
1
Cleared 510(K)
K
87
4962
FORCEPS CLIPRACK VENTRICULAR CANNULA SAWS SPATULAS
1
Cleared 510(K)
K
87
4630
RANGE OF TITANIUM NEUROSURGERY INSTRUMENTS
1
Cleared 510(K)
K
86
3416
RAYLOR MINI-PROBE
1
Cleared 510(K)
K
86
3415
RAYLOR BONE IMPACTORS
1
Cleared 510(K)
K
86
2331
FUJITSU MALLEABLE - TIP BRAIN SPATULA
1
Cleared 510(K)
K
86
1630
NEUROSURGICAL INSTURMENTS (VARIOUS)
1
Cleared 510(K)
K
83
2343
DERMALAND DURAL HOOKS
1
Cleared 510(K)
K
82
2048
H-H NERVE ROOT RETRACTOR
1
Cleared 510(K)
K
82
1357
MODIFIED NEURO SURGERY NIBBLING FORCEPS
1
Cleared 510(K)
K
80
2726
INSTRUMENTS NONSTERILE & STERILE
1
Cleared 510(K)
K
80
1760
FIELD-LEE BRAIN BIOPSY NEEDLE
1
Cleared 510(K)
K
78
0579
SUBCUPASS TUNNELING TOOL
1
Cleared 510(K)
K
78
0520
VAS APPROXIMATOR
1
Cleared 510(K)
K
77
2371
BAYONET SURGICAL INSTRUMENTS
1
Cleared 510(K)
K
77
2389
DANDY HEMOSTATIC FORCEPS
1
Cleared 510(K)
K
77
2013
PERCUPASS TUNNELING TOOL MODEL 3452
1
Cleared 510(K)
K
76
1097
VANDERBILT BLADE HOLDER
1
Cleared 510(K)
K
76
1095
VANDERBILT CURETTE
1
Cleared 510(K)
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
/
HAO
/
K861630
View Source
NEUROSURGICAL INSTURMENTS (VARIOUS)
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K861630
510(k) Type
Traditional
Applicant
DOWNS SURGICAL LTD.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
5/9/1986
Days to Decision
10 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
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
K
22
0920
Matreneu Percutaneous Balloon Compression Kit
K
94
0973
MULLAN GANGLION MICROCOMPRESSION SET
K
95
1492
RIB RESECTOR
K
94
3115
AUTO SUTURE PITUITARY SPINAL RONGEUR
K
94
2969
AUTO SUTURE SPINAL NERVE HOOK
K
94
2968
AUTO SUTURE SPINAL OSTEOTOME
K
94
2970
AUTO SUTURE SPINAL ELEVATOR
K
94
2971
AUTO SUTURE SPINAL DISSECTOR
K
94
2967
AUTO SUTURE SPINAL CURETTE
K
92
3723
SILICONE BRAIN SPATULA SET
K
91
0226
DURAL DISSECTORS
K
91
0225
BONE PAD REMOVER
K
90
2850
ZEPPELIN INSTRUMENTS
K
89
2546
TAYLOR SPINAL RETRACTOR
K
88
2422
DISPOSABLE ARACHNOID KNIFE
K
88
0278
MALLEABLE PTFE COATED BRAIN SPATULAE
K
87
4962
FORCEPS CLIPRACK VENTRICULAR CANNULA SAWS SPATULAS
K
87
4630
RANGE OF TITANIUM NEUROSURGERY INSTRUMENTS
K
86
3416
RAYLOR MINI-PROBE
K
86
3415
RAYLOR BONE IMPACTORS
K
86
2331
FUJITSU MALLEABLE - TIP BRAIN SPATULA
K
86
1630
NEUROSURGICAL INSTURMENTS (VARIOUS)
K
83
2343
DERMALAND DURAL HOOKS
K
82
2048
H-H NERVE ROOT RETRACTOR
K
82
1357
MODIFIED NEURO SURGERY NIBBLING FORCEPS
K
80
2726
INSTRUMENTS NONSTERILE & STERILE
K
80
1760
FIELD-LEE BRAIN BIOPSY NEEDLE
K
78
0579
SUBCUPASS TUNNELING TOOL
K
78
0520
VAS APPROXIMATOR
K
77
2371
BAYONET SURGICAL INSTRUMENTS
K
77
2389
DANDY HEMOSTATIC FORCEPS
K
77
2013
PERCUPASS TUNNELING TOOL MODEL 3452
K
76
1097
VANDERBILT BLADE HOLDER
K
76
1095
VANDERBILT CURETTE
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
/
HAO
/
K861630
View Source
NEUROSURGICAL INSTURMENTS (VARIOUS)
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K861630
510(k) Type
Traditional
Applicant
DOWNS SURGICAL LTD.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
5/9/1986
Days to Decision
10 days