FDA Browser
by
Innolitics
Anesthesiology
Review Panel
Cardiovascular
Review Panel
Chemistry
Review Panel
Dental
Review Panel
Ear, Nose, Throat
Review Panel
Miscellaneous
Miscellaneous
Subpart B—Diagnostic Devices
CFR Sub-Part
Subpart D—Prosthetic Devices
CFR Sub-Part
Subpart E—Neurological Surgical Devices
CFR Sub-Part
PGW
Ear, Nose, And Throat Stereotaxic Instrument
2
Product Code
K
23
1862
TruDi® Navigation System V3 (FG-2000-00)
2
Cleared 510(K)
K
22
3734
ENT EM
2
Cleared 510(K)
K
22
1037
TruDi Shaver Blade
2
Cleared 510(K)
K
22
1098
Scopis ENT Software, Scopis ENT Software with TGS, Scopis Planning Software, Electromagnetic Navigation Unit
2
Cleared 510(K)
K
21
1291
Cube Navigation System, VirtuEye V2, Navigation Sensor NanoRest, Navigation Unit Cube 4D
2
Cleared 510(K)
K
20
2609
Instrument Clamps Electromagnetic
2
Cleared 510(K)
K
20
1174
TruDi Curette
2
Cleared 510(K)
K
20
0723
StealthStation FlexENT (9736242), StealthStation S8 ENT Software (9735762)
2
Cleared 510(K)
K
19
3453
TruDi Probe
2
Cleared 510(K)
K
20
0041
FlexPointer 1.5 Single Use, FlexTube 3 Single Use
2
Cleared 510(K)
K
19
3118
TGS Guidewire and updated Scopis Software
2
Cleared 510(K)
K
19
3502
TGS Universal Headrest with Mounting Arm
2
Cleared 510(K)
K
19
2397
TruDi Navigation System
2
Cleared 510(K)
K
19
0532
TruDi NAV Wire
2
Cleared 510(K)
K
18
0948
TruDi NAV Suction Instruments
2
Cleared 510(K)
K
17
3628
Acclarent ENT Navigation System
2
Cleared 510(K)
K
17
1661
Scopis Extended Instrument Set EM
2
Cleared 510(K)
K
17
0018
StealthStationTM S8 ENT Software
2
Cleared 510(K)
K
16
3416
Fiagon Navigation – PointerTube Straight and PointerTube Keat
2
Cleared 510(K)
K
16
1491
Scopis Hybrid Navigation System EM
2
Cleared 510(K)
K
16
2176
Fiagon Navigation System
2
Cleared 510(K)
K
16
1697
Acclarent NavWire Sinus Navigation Guidewire
2
Cleared 510(K)
K
16
1701
CARTO ENT System
2
Cleared 510(K)
K
16
1555
KARL STORZ NAV1 Electromagnetic Navigation System
2
Cleared 510(K)
K
16
1940
Guidewire 0.6 Single Use
2
Cleared 510(K)
K
15
3555
EM ENT Navigated Suctions
2
Cleared 510(K)
K
16
0479
PointerShell Universal, PointerShell LS
2
Cleared 510(K)
K
16
0369
GuideWire
2
Cleared 510(K)
K
15
3247
Fusion Compact Navigation System
2
Cleared 510(K)
K
15
0473
FlexPointer 1.5 mm
2
Cleared 510(K)
K
14
1456
THE FIAGON NAVIGATION - EXTENDED INSTRUMENT SET ENT, REGISTRATIONPOINTER, VENTERAPOINTER, GUIDEWIRE, POINTERSHELL
2
Cleared 510(K)
K
14
1551
PROFESS SOFTWARE, PROFESS CURVED 70 (DEGREES) SUCTION, PROFESS CURVED 70 (DEGREES) SUCTION, PROFESS CURVED 90 (DEGREES)
2
Cleared 510(K)
K
13
3573
FIAGON NAVIGATION SYSTEM
2
Cleared 510(K)
K
13
3665
MALLEABLE SUCTION INSTRUMENTS
2
Cleared 510(K)
Subpart E—Surgical Devices
CFR Sub-Part
Subpart F—General Hospital and Personal Use Therapeutic Devices
CFR Sub-Part
Subpart F—Therapeutic Devices
CFR Sub-Part
Subpart G—General Hospital and Personal Use Miscellaneous Devices
CFR Sub-Part
Subpart G—Miscellaneous Devices
CFR Sub-Part
Gastroenterology and Urology
Review Panel
General Hospital
Review Panel
Hematology
Review Panel
Immunology
Review Panel
Microbiology
Review Panel
Neurology
Review Panel
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
EN
/
subpart-e—neurological-surgical-devices
/
PGW
/
K141551
View Source
PROFESS SOFTWARE, PROFESS CURVED 70 (DEGREES) SUCTION, PROFESS CURVED 70 (DEGREES) SUCTION, PROFESS CURVED 90 (DEGREES)
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K141551
510(k) Type
Traditional
Applicant
STRYKER CORPORATE
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
9/8/2014
Days to Decision
89 days
Submission Type
Summary
FDA Browser
by
Innolitics
Anesthesiology
Cardiovascular
Chemistry
Dental
Ear, Nose, Throat
Miscellaneous
Subpart B—Diagnostic Devices
Subpart D—Prosthetic Devices
Subpart E—Neurological Surgical Devices
PGW
Ear, Nose, And Throat Stereotaxic Instrument
K
23
1862
TruDi® Navigation System V3 (FG-2000-00)
K
22
3734
ENT EM
K
22
1037
TruDi Shaver Blade
K
22
1098
Scopis ENT Software, Scopis ENT Software with TGS, Scopis Planning Software, Electromagnetic Navigation Unit
K
21
1291
Cube Navigation System, VirtuEye V2, Navigation Sensor NanoRest, Navigation Unit Cube 4D
K
20
2609
Instrument Clamps Electromagnetic
K
20
1174
TruDi Curette
K
20
0723
StealthStation FlexENT (9736242), StealthStation S8 ENT Software (9735762)
K
19
3453
TruDi Probe
K
20
0041
FlexPointer 1.5 Single Use, FlexTube 3 Single Use
K
19
3118
TGS Guidewire and updated Scopis Software
K
19
3502
TGS Universal Headrest with Mounting Arm
K
19
2397
TruDi Navigation System
K
19
0532
TruDi NAV Wire
K
18
0948
TruDi NAV Suction Instruments
K
17
3628
Acclarent ENT Navigation System
K
17
1661
Scopis Extended Instrument Set EM
K
17
0018
StealthStationTM S8 ENT Software
K
16
3416
Fiagon Navigation – PointerTube Straight and PointerTube Keat
K
16
1491
Scopis Hybrid Navigation System EM
K
16
2176
Fiagon Navigation System
K
16
1697
Acclarent NavWire Sinus Navigation Guidewire
K
16
1701
CARTO ENT System
K
16
1555
KARL STORZ NAV1 Electromagnetic Navigation System
K
16
1940
Guidewire 0.6 Single Use
K
15
3555
EM ENT Navigated Suctions
K
16
0479
PointerShell Universal, PointerShell LS
K
16
0369
GuideWire
K
15
3247
Fusion Compact Navigation System
K
15
0473
FlexPointer 1.5 mm
K
14
1456
THE FIAGON NAVIGATION - EXTENDED INSTRUMENT SET ENT, REGISTRATIONPOINTER, VENTERAPOINTER, GUIDEWIRE, POINTERSHELL
K
14
1551
PROFESS SOFTWARE, PROFESS CURVED 70 (DEGREES) SUCTION, PROFESS CURVED 70 (DEGREES) SUCTION, PROFESS CURVED 90 (DEGREES)
K
13
3573
FIAGON NAVIGATION SYSTEM
K
13
3665
MALLEABLE SUCTION INSTRUMENTS
Subpart E—Surgical Devices
Subpart F—General Hospital and Personal Use Therapeutic Devices
Subpart F—Therapeutic Devices
Subpart G—General Hospital and Personal Use Miscellaneous Devices
Subpart G—Miscellaneous Devices
Gastroenterology and Urology
General Hospital
Hematology
Immunology
Microbiology
Neurology
Obstetrical and Gynecological
Ophthalmic
Orthopedic
Pathology
Physical Medicine
Radiology
General and Plastic Surgery
Toxicology
Medical Genetics
Unknown
EN
/
subpart-e—neurological-surgical-devices
/
PGW
/
K141551
View Source
PROFESS SOFTWARE, PROFESS CURVED 70 (DEGREES) SUCTION, PROFESS CURVED 70 (DEGREES) SUCTION, PROFESS CURVED 90 (DEGREES)
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K141551
510(k) Type
Traditional
Applicant
STRYKER CORPORATE
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
9/8/2014
Days to Decision
89 days
Submission Type
Summary