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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
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
K
22
3596
SQ.line KERRISON
2
Cleared 510(K)
K
23
0256
Rebellion, Phantom Multi-Bite Kerrison Rongeur
2
Cleared 510(K)
K
22
1818
Rebellion; Phantom Multi-Bite Kerrison Rongeur
2
Cleared 510(K)
K
21
0741
KLS Martin Neuro Rongeurs
2
Cleared 510(K)
K
20
0768
Rebellion, Phantom Multi-Bite Kerrison Rongeur
2
Cleared 510(K)
K
20
0387
Ace Medical Surgical Instruments
2
Cleared 510(K)
K
20
0383
Wiggins Medical Surgical Instruments
2
Cleared 510(K)
K
18
0949
Steribite
2
Cleared 510(K)
K
16
1744
Symmetry Sharp Kerrison Rongeur
2
Cleared 510(K)
K
15
3243
Fehling-Punches
2
Cleared 510(K)
K
15
2734
Kerrison Rongeurs
2
Cleared 510(K)
K
15
0468
Laminectomy Rongeurs, Kerrison Rongeurs, IVD Rongeurs
2
Cleared 510(K)
K
15
0428
Integra (R) Jarit (R) Kerrison Rongeurs, Integra (R) Ruggles (TM)-Redmons (TM) Kerrison Rongeurs, Integra (R) Miltex (R) Kerrison Rongeurs, Integra (R) Meisterhand (R) Kerrison Rongeurs
2
Cleared 510(K)
K
13
1851
OSTEOMED NEURO RONGEUR
2
Cleared 510(K)
K
13
0541
SYMMETRY KERRISON DISPOSABLE TIP RONGEURS
2
Cleared 510(K)
K
11
3073
IO-TOME DEVICE
2
Cleared 510(K)
K
11
3533
NEURO CHECK DEVICE WITH IO-FLEX WIRE
2
Cleared 510(K)
K
10
0958
MODIFICATION TO: MICROBLADE SHAVER AND ACCESSORIES
2
Cleared 510(K)
K
09
2227
JARIT, RUGGLES, R&B REDMOND/ REDMOND, MILTEX, MEISTERHAND - KERRISON RONGEURS
2
Cleared 510(K)
K
08
1651
INSTRUMED RONGEUR
2
Cleared 510(K)
K
08
0494
BAXANO ULTRA LOW PROFILE RONGEUR
2
Cleared 510(K)
K
06
3231
MICROBLADE SHAVER AND ACCESSORIES
2
Cleared 510(K)
K
06
2711
ULTRA LOW PROFILE RONGEUR
2
Cleared 510(K)
K
02
3868
DAN KERRISON RONGEURS, MODELS K1 + BILLY 1
2
Cleared 510(K)
K
95
4699
BRAY RONGEUR
2
Cleared 510(K)
K
94
3583
KERRISON RONGEURS
2
Cleared 510(K)
K
94
3635
ULTRA-LINE RONGEUR
2
Cleared 510(K)
K
94
3116
AUTO SUTURE KERRISON SPINAL RONGEUR
2
Cleared 510(K)
K
93
3978
NEDBOND EJECTOR KERRISON RONGEUR
2
Cleared 510(K)
K
90
3151
INTERVERTEBRAL DISC RONGEUR
2
Cleared 510(K)
K
90
3401
SPECIAL RONGEUR
2
Cleared 510(K)
K
90
1313
INSTRUMENTS FOR NEUROLOGICAL SURGERY
2
Cleared 510(K)
K
90
1372
LAMINECTOMY RONGEUR
2
Cleared 510(K)
K
89
2535
NEUROLOGICAL RONGEURS - VARIOUS TYPES
2
Cleared 510(K)
K
87
5043
RONGEUR (NEUROSURGICAL INSTRUMENTS)
2
Cleared 510(K)
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
/
HAE
/
K152734
View Source
Kerrison Rongeurs
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K152734
510(k) Type
Traditional
Applicant
VITALITEC MEDIZINTECHNIK GMBH
Country
Germany
FDA Decision
Substantially Equivalent
Decision Date
6/18/2016
Days to Decision
270 days
Submission Type
Summary
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
K
22
3596
SQ.line KERRISON
K
23
0256
Rebellion, Phantom Multi-Bite Kerrison Rongeur
K
22
1818
Rebellion; Phantom Multi-Bite Kerrison Rongeur
K
21
0741
KLS Martin Neuro Rongeurs
K
20
0768
Rebellion, Phantom Multi-Bite Kerrison Rongeur
K
20
0387
Ace Medical Surgical Instruments
K
20
0383
Wiggins Medical Surgical Instruments
K
18
0949
Steribite
K
16
1744
Symmetry Sharp Kerrison Rongeur
K
15
3243
Fehling-Punches
K
15
2734
Kerrison Rongeurs
K
15
0468
Laminectomy Rongeurs, Kerrison Rongeurs, IVD Rongeurs
K
15
0428
Integra (R) Jarit (R) Kerrison Rongeurs, Integra (R) Ruggles (TM)-Redmons (TM) Kerrison Rongeurs, Integra (R) Miltex (R) Kerrison Rongeurs, Integra (R) Meisterhand (R) Kerrison Rongeurs
K
13
1851
OSTEOMED NEURO RONGEUR
K
13
0541
SYMMETRY KERRISON DISPOSABLE TIP RONGEURS
K
11
3073
IO-TOME DEVICE
K
11
3533
NEURO CHECK DEVICE WITH IO-FLEX WIRE
K
10
0958
MODIFICATION TO: MICROBLADE SHAVER AND ACCESSORIES
K
09
2227
JARIT, RUGGLES, R&B REDMOND/ REDMOND, MILTEX, MEISTERHAND - KERRISON RONGEURS
K
08
1651
INSTRUMED RONGEUR
K
08
0494
BAXANO ULTRA LOW PROFILE RONGEUR
K
06
3231
MICROBLADE SHAVER AND ACCESSORIES
K
06
2711
ULTRA LOW PROFILE RONGEUR
K
02
3868
DAN KERRISON RONGEURS, MODELS K1 + BILLY 1
K
95
4699
BRAY RONGEUR
K
94
3583
KERRISON RONGEURS
K
94
3635
ULTRA-LINE RONGEUR
K
94
3116
AUTO SUTURE KERRISON SPINAL RONGEUR
K
93
3978
NEDBOND EJECTOR KERRISON RONGEUR
K
90
3151
INTERVERTEBRAL DISC RONGEUR
K
90
3401
SPECIAL RONGEUR
K
90
1313
INSTRUMENTS FOR NEUROLOGICAL SURGERY
K
90
1372
LAMINECTOMY RONGEUR
K
89
2535
NEUROLOGICAL RONGEURS - VARIOUS TYPES
K
87
5043
RONGEUR (NEUROSURGICAL INSTRUMENTS)
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
/
HAE
/
K152734
View Source
Kerrison Rongeurs
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K152734
510(k) Type
Traditional
Applicant
VITALITEC MEDIZINTECHNIK GMBH
Country
Germany
FDA Decision
Substantially Equivalent
Decision Date
6/18/2016
Days to Decision
270 days
Submission Type
Summary