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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
K
17
2907
ELAN 4 Air Motor System
2
Cleared 510(K)
K
16
3182
Medtronic Legend Pneumatic; MR7 Pneumatic; Triton Pneumatic Drill System incorporating various Pneumatic Handpieces; Attachments; Surgical Dissecting Tools; and System Accessories
2
Cleared 510(K)
K
15
0801
Stryker Maestro Air Motors
2
Cleared 510(K)
K
10
1168
LEGEND POWER ADAPTER MODEL: 6475000
2
Cleared 510(K)
K
09
3361
SYNTHES AIR PEN DRIVE (APD) SYSTEM
2
Cleared 510(K)
K
09
0112
MIDAS REX MR7 PNEUMATIC HIGH SPEED SYSTEM, MODELS PM700, PM710, PC700, PC710, PC720, PA700
2
Cleared 510(K)
K
06
1297
ANSPACH IMRI SAFE SURGICAL DRILL SYSTEM
2
Cleared 510(K)
K
06
1725
STRYKER ARIA PNEUMATIC SYSTEM
2
Cleared 510(K)
K
04
2974
MEDICON VIPAIR HIGH SPEED SYSTEM
2
Cleared 510(K)
K
04
1754
STRYKER MAESTRO SYSTEM
2
Cleared 510(K)
K
04
0186
ANSPACH MRI SAFE SURGICAL DRILL SYSTEM
2
Cleared 510(K)
K
02
3066
DRILL GUIDE ATTACHMENT (PN 3105 DG) OF THE SODEM HIGH SPEED SYSTEM (PNEUMATIC)
2
Cleared 510(K)
K
02
0069
MEDTRONIC MIDA REX LEGEND SYSTEM, MIDAS REX LEGEND PNEUMATIC HIGH SPEED SYSTEM OR LEGEND SYSTEM
2
Cleared 510(K)
K
01
3091
ZMM 2000 ZEPPELIN MILLENNIUM MOTORDRILL SYSTEM
2
Cleared 510(K)
K
00
0195
CRANIAL DRILL
2
Cleared 510(K)
K
99
3851
SODEM PERFORATOR DRIVE
2
Cleared 510(K)
K
99
4175
MODIFICATION TO SODEM HIGH SPEED SYSTEM FOR NEUROSURGICAL USE
2
Cleared 510(K)
K
99
1625
KOMET XK-95 PERFORATOR MOTOR (MI-102)
2
Cleared 510(K)
K
98
3092
TRITON HUDSON CHUCK ATTACHMENT
2
Cleared 510(K)
K
98
0686
AESCULAP HILAN MOTOR SYSTEM
2
Cleared 510(K)
K
97
2289
MIDAS REX MOTOR
2
Cleared 510(K)
K
95
4717
SODEM HIGH SPEED SYSTEM FOR NEUROSURGERY & MEDIAN STERNOTOMY
2
Cleared 510(K)
K
96
2483
MIDAS REX III MOTOR
2
Cleared 510(K)
K
96
0630
ANSPAHC SPEED REDUCER
2
Cleared 510(K)
K
95
3434
MIDAS REX MOTORS, (MIDAS I, MIDAS II & CONVERTIBLE MODELS)
2
Cleared 510(K)
K
89
5739
MICROMEDICS SURGICAL DRILL SYSTEM
2
Cleared 510(K)
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 6 December 2024 at 11:05 pm
NE
/
subpart-e—neurological-surgical-devices
/
HBB
/
K991625
View Source
KOMET XK-95 PERFORATOR MOTOR (MI-102)
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K991625
510(k) Type
Traditional
Applicant
KOMET MEDICAL
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
7/30/1999
Days to Decision
80 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
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
K
17
2907
ELAN 4 Air Motor System
K
16
3182
Medtronic Legend Pneumatic; MR7 Pneumatic; Triton Pneumatic Drill System incorporating various Pneumatic Handpieces; Attachments; Surgical Dissecting Tools; and System Accessories
K
15
0801
Stryker Maestro Air Motors
K
10
1168
LEGEND POWER ADAPTER MODEL: 6475000
K
09
3361
SYNTHES AIR PEN DRIVE (APD) SYSTEM
K
09
0112
MIDAS REX MR7 PNEUMATIC HIGH SPEED SYSTEM, MODELS PM700, PM710, PC700, PC710, PC720, PA700
K
06
1297
ANSPACH IMRI SAFE SURGICAL DRILL SYSTEM
K
06
1725
STRYKER ARIA PNEUMATIC SYSTEM
K
04
2974
MEDICON VIPAIR HIGH SPEED SYSTEM
K
04
1754
STRYKER MAESTRO SYSTEM
K
04
0186
ANSPACH MRI SAFE SURGICAL DRILL SYSTEM
K
02
3066
DRILL GUIDE ATTACHMENT (PN 3105 DG) OF THE SODEM HIGH SPEED SYSTEM (PNEUMATIC)
K
02
0069
MEDTRONIC MIDA REX LEGEND SYSTEM, MIDAS REX LEGEND PNEUMATIC HIGH SPEED SYSTEM OR LEGEND SYSTEM
K
01
3091
ZMM 2000 ZEPPELIN MILLENNIUM MOTORDRILL SYSTEM
K
00
0195
CRANIAL DRILL
K
99
3851
SODEM PERFORATOR DRIVE
K
99
4175
MODIFICATION TO SODEM HIGH SPEED SYSTEM FOR NEUROSURGICAL USE
K
99
1625
KOMET XK-95 PERFORATOR MOTOR (MI-102)
K
98
3092
TRITON HUDSON CHUCK ATTACHMENT
K
98
0686
AESCULAP HILAN MOTOR SYSTEM
K
97
2289
MIDAS REX MOTOR
K
95
4717
SODEM HIGH SPEED SYSTEM FOR NEUROSURGERY & MEDIAN STERNOTOMY
K
96
2483
MIDAS REX III MOTOR
K
96
0630
ANSPAHC SPEED REDUCER
K
95
3434
MIDAS REX MOTORS, (MIDAS I, MIDAS II & CONVERTIBLE MODELS)
K
89
5739
MICROMEDICS SURGICAL DRILL SYSTEM
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
/
HBB
/
K991625
View Source
KOMET XK-95 PERFORATOR MOTOR (MI-102)
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K991625
510(k) Type
Traditional
Applicant
KOMET MEDICAL
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
7/30/1999
Days to Decision
80 days
Submission Type
Statement