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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
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
K
23
1403
evoDrill Cranial Perforator
2
Cleared 510(K)
K
21
3228
NeuroLine Disposable Cranial Perforator with Hudson end
2
Cleared 510(K)
K
18
3581
Codman Disposable Perforators
2
Cleared 510(K)
K
14
1455
EASYDRILL AUTOSTOP CRANIAL PERFORATOR
2
Cleared 510(K)
K
12
1253
MERIDIAN CRANIAL PERFORATOR
2
Cleared 510(K)
K
08
2010
STRYKER DISPOSABLE CRANIAL PERFORATOR BIT
2
Cleared 510(K)
K
08
2637
CRANIAL PERFORATOR
2
Cleared 510(K)
K
07
3336
CODMAN CRANIOTOMY KIT, MODELS 26-1229, 26-1230, 26-1231
2
Cleared 510(K)
K
07
1931
CODMAN DISPOSABLE PERFORATOR, MODEL(S) 26-1222, 26-1223
2
Cleared 510(K)
K
03
2970
ACRA-CUT XPRESS 120
2
Cleared 510(K)
K
98
2991
ANSPACH ACCESS CRANIAL PERFORATOR
2
Cleared 510(K)
K
93
3894
DISPOSABLE PERFORATOR
2
Cleared 510(K)
K
92
4242
DISPOSABLE PERFORATOR
2
Cleared 510(K)
K
89
2866
AUTOMATIC CRANIAL DRILL (PERFORATOR)
2
Cleared 510(K)
K
87
5019
GHAJAR GUIDE SYSTEM FOR THE PERFORATOR
2
Cleared 510(K)
K
83
3266
ACRA-CUT
2
Cleared 510(K)
K
82
0087
CODMAN * REUSABLE PERFORATOR
2
Cleared 510(K)
K
79
1101
DISPOSABLE PERFORATORS, JACOBS, HUDSON
2
Cleared 510(K)
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
/
HBF
/
K833266
View Source
ACRA-CUT
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K833266
510(k) Type
Traditional
Applicant
ACRA CUT, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
12/29/1983
Days to Decision
99 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
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)
K
23
1403
evoDrill Cranial Perforator
K
21
3228
NeuroLine Disposable Cranial Perforator with Hudson end
K
18
3581
Codman Disposable Perforators
K
14
1455
EASYDRILL AUTOSTOP CRANIAL PERFORATOR
K
12
1253
MERIDIAN CRANIAL PERFORATOR
K
08
2010
STRYKER DISPOSABLE CRANIAL PERFORATOR BIT
K
08
2637
CRANIAL PERFORATOR
K
07
3336
CODMAN CRANIOTOMY KIT, MODELS 26-1229, 26-1230, 26-1231
K
07
1931
CODMAN DISPOSABLE PERFORATOR, MODEL(S) 26-1222, 26-1223
K
03
2970
ACRA-CUT XPRESS 120
K
98
2991
ANSPACH ACCESS CRANIAL PERFORATOR
K
93
3894
DISPOSABLE PERFORATOR
K
92
4242
DISPOSABLE PERFORATOR
K
89
2866
AUTOMATIC CRANIAL DRILL (PERFORATOR)
K
87
5019
GHAJAR GUIDE SYSTEM FOR THE PERFORATOR
K
83
3266
ACRA-CUT
K
82
0087
CODMAN * REUSABLE PERFORATOR
K
79
1101
DISPOSABLE PERFORATORS, JACOBS, HUDSON
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
/
HBF
/
K833266
View Source
ACRA-CUT
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K833266
510(k) Type
Traditional
Applicant
ACRA CUT, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
12/29/1983
Days to Decision
99 days