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
Subpart E—Surgical Devices
CFR Sub-Part
EQL
Laryngostroboscope
1
Product Code
EOQ
Bronchoscope (Flexible Or Rigid)
2
Product Code
EOX
Esophagoscope (Flexible Or Rigid)
2
Product Code
BST
Curette, Biopsy, Bronchoscope (Non-Rigid)
2
Product Code
BTG
Brush, Biopsy, Bronchoscope (Non-Rigid)
2
Product Code
BWH
Forceps, Biopsy, Bronchoscope (Non-Rigid)
2
Product Code
EMX
Balloon, Epistaxis
1
Product Code
ENW
Catheter, Nasopharyngeal
1
Product Code
ENZ
Telescope, Laryngeal-Bronchial
2
Product Code
EOB
Nasopharyngoscope (Flexible Or Rigid)
2
Product Code
EQH
Source, Carrier, Fiberoptic Light
1
Product Code
EQJ
Bur, Ear, Nose And Throat
1
Product Code
EQN
Laryngoscope, Nasopharyngoscope
2
Product Code
ERA
Otoscope
1
Product Code
ERL
Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
2
Product Code
EWG
Laser, Ent Microsurgical Carbon-Dioxide
2
Product Code
EWQ
Saw, Surgical, Ent (Electric Or Pneumatic)
1
Product Code
EWY
Mediastinoscope, Surgical
2
Product Code
JEI
Claw, Foreign Body, Bronchoscope (Non-Rigid)
2
Product Code
JEJ
Tubing, Instrumentation, Bronchoscope (Brush Sheath A/O Aspirating)
2
Product Code
JEK
Forceps, Biopsy, Bronchoscope (Rigid)
2
Product Code
JEL
Curette, Biopsy, Bronchoscope (Rigid)
2
Product Code
JYE
Chisel, Middle-Ear
1
Product Code
JYF
Clamp, Ossicle Holding
1
Product Code
JYG
Curette, Ear
1
Product Code
JYH
Excavator, Ear
1
Product Code
JYI
Gauge, Mastoid
1
Product Code
JYJ
Gauge, Measuring
1
Product Code
JYL
Hook, Microsurgical Ear
1
Product Code
JYM
Inserter, Myringotomy Tube
1
Product Code
JYN
Inserter, Sacculotomy Tack
1
Product Code
JYO
Knife, Ear
1
Product Code
JYP
Knife, Myringotomy
1
Product Code
JYQ
Loop, Wire
1
Product Code
JYR
Nipper, Malleus
1
Product Code
JYS
Perforator, Ear-Lobe
1
Product Code
JYT
Pick, Microsurgical Ear
1
Product Code
JYW
Press, Vein
1
Product Code
JYX
Punch, Attic
1
Product Code
JYY
Rasp, Ear
1
Product Code
JYZ
Rod, Measuring Ear
1
Product Code
JZA
Rongeur, Mastoid
1
Product Code
JZB
Scissors, Ear
1
Product Code
JZC
Searcher, Mastoid
1
Product Code
JZD
Snare, Ear
1
Product Code
JZE
Spoon, Ear
1
Product Code
JZF
Tube, Ear Suction
1
Product Code
JZY
Knife, Laryngeal
1
Product Code
JZZ
Saw, Laryngeal
1
Product Code
KAA
Set, Laryngeal Injection
1
Product Code
KAB
Trocar, Laryngeal
1
Product Code
KAC
Tube, Laryngectomy
1
Product Code
KAD
Elevator, Ent
1
Product Code
KAE
Forceps, Ent
1
Product Code
KAH
Microrule, Ent
1
Product Code
KAI
Mirror, Ent
1
Product Code
KAJ
Mobilizer, Ent
1
Product Code
KAK
Probe, Ent
1
Product Code
KAL
Retractor, Ent
1
Product Code
KAO
Curette, Ethmoid
1
Product Code
KAP
Curette, Nasal
1
Product Code
KAQ
Gouge, Nasal, Ent
1
Product Code
KAR
Irrigator, Sinus
1
Product Code
KAS
Knife, Nasal
1
Product Code
KAT
Perforator, Antrum
1
Product Code
KAW
Punch, Antrum
1
Product Code
KAX
Punch, Ethmoid
1
Product Code
KAY
Punch, Nasal
1
Product Code
KAZ
Rasp, Frontal-Sinus
1
Product Code
KBA
Rasp, Nasal
1
Product Code
KBB
Rongeur, Nasal
1
Product Code
KBC
Saw, Nasal
1
Product Code
KBD
Scissors, Nasal
1
Product Code
KBE
Snare, Nasal
1
Product Code
KBF
Trephine, Sinus
1
Product Code
KBG
Trocar, Sinus
1
Product Code
KBH
Adenotome
1
Product Code
KBI
Bougie, Eustachian
1
Product Code
KBJ
Curette, Adenoid
1
Product Code
KBK
Curette, Salpingeal
1
Product Code
KBL
Depressor, Metal Tongue, Surgical
1
Product Code
KBM
Dissector, Tonsil
1
Product Code
KBN
Gag, Mouth
1
Product Code
KBO
Guillotine, Tonsil
1
Product Code
KBP
Hook, Tonsil Suturing
1
Product Code
KBQ
Knife, Tonsil
1
Product Code
KBR
Needle, Tonsil Suturing
1
Product Code
KBS
Punch, Adenoid
1
Product Code
KBT
Punch, Tonsil
1
Product Code
KBW
Screw, Oral
1
Product Code
KBX
Screw, Tonsil
1
Product Code
KBY
Set, Filliform, Eustachian
1
Product Code
KBZ
Snare, Tonsil
1
Product Code
KCA
Tonsillectome
1
Product Code
KCB
Tube, Tonsil Suction
1
Product Code
KCC
Bistoury, Tracheal
1
Product Code
KCD
Bougie, Esophageal, Ent
1
Product Code
KCF
Dilator, Esophageal, Ent
1
Product Code
KCG
Dilator, Tracheal
1
Product Code
KCH
Hook, Tracheal
1
Product Code
KCI
Trocar, Tracheal
1
Product Code
KTE
Trocar, Ent
1
Product Code
KTF
Punch, Ent
1
Product Code
KTG
Knife, Ent
1
Product Code
KTI
Bronchoscope Accessory
2
Product Code
KTR
Tube, Aspirating, Bronchoscope, Rigid
2
Product Code
LJW
Tracheotome
1
Product Code
LMS
Laser, Microsurgical Argon, For Uses Other Than Otology, Including Laryngology & General Use In Otolaryngology
2
Product Code
LRC
Instrument, Ent Manual Surgical
1
Product Code
K
23
0258
BB 8 Sinus Dilation Kit
1
Cleared 510(K)
K
21
2774
VenSure LightGuide
1
Cleared 510(K)
K
20
1398
SINUSPRIME Dilation System
1
Cleared 510(K)
K
20
1115
Next Generation Balloon Dilation System
1
Cleared 510(K)
K
20
1472
VenSure Balloon Device, VenSure Nav Balloon Device
1
Cleared 510(K)
K
18
1546
Dillard Nasal Balloon Catheter
1
Cleared 510(K)
K
19
0525
RELIEVA ULTIRRA Sinus Balloon Catheter
1
Cleared 510(K)
K
18
1838
Sinusway Dilation System
1
Cleared 510(K)
K
17
2737
MESIRE - Balloon Sinus Dilatation System
1
Cleared 510(K)
K
17
1687
Relieva SpinPlus Nav Balloon Sinuplasty System
1
Cleared 510(K)
K
16
1698
Relieva UltirraNav Sinus Balloon Catheter
1
Cleared 510(K)
K
16
0770
Vent-Os Sinus Dilation family
1
Cleared 510(K)
K
15
3341
Relieva Scout Multi-Sinus Dilation System
1
Cleared 510(K)
K
15
2121
NuVent EM Sinus Dilation System
1
Cleared 510(K)
K
15
2435
PassAssist LED Light Fiber
1
Cleared 510(K)
K
15
2434
XprESS Multi-Sinus Dilation System
1
Cleared 510(K)
K
14
3738
DSS Sinusplasty Balloon Catheter
1
Cleared 510(K)
K
14
3541
Relieva SpinPlus Balloon Sinuplasty System
1
Cleared 510(K)
K
15
0172
ACCLARENT SE Inflation Device
1
Cleared 510(K)
K
14
2252
XprESS Multi-Sinus Dilation Tool
1
Cleared 510(K)
K
14
1916
PATHASSIST LED LIGHT FIBER
1
Cleared 510(K)
K
14
0160
RELIEVA SCOUT SINUS DILATION SYSTEM
1
Cleared 510(K)
K
13
3563
PATHASSIST LIGHT SEEKER
1
Cleared 510(K)
K
13
0736
BLOM-SINGER ADJUSTABLE BI-FIANGED FISTULA PROSTHESIS
1
Cleared 510(K)
K
13
3016
VENT-OS SINUS DILATION SYSTEM
1
Cleared 510(K)
K
13
2297
EM SINUS DILATION SYSTEM
1
Cleared 510(K)
K
13
2440
XPRESS MULTI-SINUS DILATION TOOL
1
Cleared 510(K)
K
13
1709
SINUS DILATION SYSTEM WITH CANNULATED INSTRUMENT
1
Cleared 510(K)
K
13
0503
PATHASSIST LED LIGHT FIBER
1
Cleared 510(K)
K
12
0280
RELIEVA SEEKER BALLOON SINUPLASTY SYSTEM
1
Cleared 510(K)
K
12
1351
SINUS DILATION SYSTEM
1
Cleared 510(K)
K
12
1943
XPRESS MULTI-SINUS DILATION TOOL
1
Cleared 510(K)
K
12
1174
XPRESS MULTI-SINUS DILATION TOOL
1
Cleared 510(K)
K
12
0962
PATHASSIST LIGHT FIBER
1
Cleared 510(K)
K
12
0735
PATHASSIT LIGHT SEEKER
1
Cleared 510(K)
K
11
3522
PATHASSIST LIGHT SEEKER
1
Cleared 510(K)
K
11
2506
XPRESS MULTI-SINUS DILATION TOOL
1
Cleared 510(K)
K
11
1875
RELIEVA SPIN SINUS DILATION SYSTEM
1
Cleared 510(K)
K
11
1763
PATHASSIST LIGHT FIBER
1
Cleared 510(K)
K
11
1254
RELIEVA SOLO ELITE SINUS BALLOON CATHETER
1
Cleared 510(K)
K
11
0739
ENTELLUS MEDICAL SINUS GUIDEWIRE
1
Cleared 510(K)
K
11
0158
ILLUMINATING SINUS SEEKER
1
Cleared 510(K)
K
10
2003
XPRESS BALLOON DEVICE
1
Cleared 510(K)
K
09
3007
ENTELLUS MEDICAL BALLOON DEVICE
1
Cleared 510(K)
K
09
1681
FINESS SINUS TREATMENT SYSTEM (ACCESS SHEATH COMPONENT)
1
Cleared 510(K)
K
08
1542
MODIFICATION TO ENTELLUS MEDICAL RS-SERIES SYSTEM
1
Cleared 510(K)
K
07
2302
ENTELLUS MEDICAL RS-SERIES SYSTEM
1
Cleared 510(K)
K
06
1903
RELIEVA SINUS BALLOON CATHETER
1
Cleared 510(K)
K
05
2198
RELIEVA SINUS BALLOON INFLATION DEVICE
1
Cleared 510(K)
K
04
3527
RELIEVA SINUS BALLOON DILATION CATHETER
1
Cleared 510(K)
K
99
0366
EXMOOR SUCTION CLEARANCE KIT
1
Cleared 510(K)
K
97
0018
FAST TRACT TRANSTRACHEAL PROCEDURE KIT
1
Cleared 510(K)
K
94
2745
EXMOOR SINGLE USE MYRINGOTOMES
1
Cleared 510(K)
K
94
2746
SUCKER ENDS (ZOELLNER)
1
Cleared 510(K)
K
94
2064
DISPOSABLE NASAL RONGEUR
1
Cleared 510(K)
K
94
2063
DISPOSABLE NASAL SCISSOR
1
Cleared 510(K)
K
94
2065
DISPOSABLE ENT PUNCH
1
Cleared 510(K)
K
93
3770
FORCEPS, ENT INSTR, ENT MANUAL SURG RETRACT/ALL TYPE
1
Cleared 510(K)
K
93
1793
SYMBIOSIS ENT SURGICAL INSTRUMENTS
1
Cleared 510(K)
K
93
0292
HOUSE-BELLUCCI ALLIGATOR SCISSORS
1
Cleared 510(K)
K
92
0988
ATMOS MIRROR WARMER
1
Cleared 510(K)
K
89
2504
'EXMOOR' SINGLE USE SUCTION TUBE
1
Cleared 510(K)
K
88
4631
FLEXIBLE ENDOSCOPE 91-8200(90) AND 91-82100(135)
1
Cleared 510(K)
K
87
3044
POREX OTOLOGY INSTRUMENTS
1
Cleared 510(K)
K
86
4938
'EXMOOR' MOFFAT-ROBINSON BONE PATE COLLECTOR
1
Cleared 510(K)
LXR
Laser, Microsurgical Argon, For Use In Otology
2
Product Code
LYA
Splint, Intranasal Septal
1
Product Code
MMO
Tray, Surgical, Ent
1
Product Code
MQW
Transilluminator, Fiber Optic
1
Product Code
MXP
Bone Particle Collector
1
Product Code
NLB
Trocar, Tracheal, Laryngeal, Sinus, Reprocessed
1
Product Code
NLE
Forceps, Biopsy, Bronchoscope (Non-Rigid), Reprocessed
2
Product Code
NLY
Microdebrider, Ent, High Speed, Single Use, Reprocessed
1
Product Code
NLZ
Bur, Ent, Diamond Coated, Single Use, Reprocessed
1
Product Code
OGR
Ear, Nose, And Throat Surgical Tray
1
Product Code
OGU
Pierced Ear/Entry Cleaning Tray
1
Product Code
PNZ
Eustachian Tube Balloon Dilation Device
2
Product Code
QGK
Balloon, Nasal Airway
1
Product Code
QJL
Splint, Intranasal Septal, Cber Led
1
Product Code
QNW
Reprocessed Bronchoscope
2
Product Code
QQH
Powered Insertion System For A Cochlear Implant Electrode Array
2
Product Code
OLL
Septal Stapler/Absorbable Staples
2
Product Code
SBS
Laryngeal Injection Set With Led Light
1
Product Code
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
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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 30 November 2024 at 11:09 am
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subpart-e—surgical-devices
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LRC
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K091681
View Source
FINESS SINUS TREATMENT SYSTEM (ACCESS SHEATH COMPONENT)
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K091681
510(k) Type
Special
Applicant
Entellus Medical, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
7/8/2009
Days to Decision
28 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
Subpart E—Surgical Devices
EQL
Laryngostroboscope
EOQ
Bronchoscope (Flexible Or Rigid)
EOX
Esophagoscope (Flexible Or Rigid)
BST
Curette, Biopsy, Bronchoscope (Non-Rigid)
BTG
Brush, Biopsy, Bronchoscope (Non-Rigid)
BWH
Forceps, Biopsy, Bronchoscope (Non-Rigid)
EMX
Balloon, Epistaxis
ENW
Catheter, Nasopharyngeal
ENZ
Telescope, Laryngeal-Bronchial
EOB
Nasopharyngoscope (Flexible Or Rigid)
EQH
Source, Carrier, Fiberoptic Light
EQJ
Bur, Ear, Nose And Throat
EQN
Laryngoscope, Nasopharyngoscope
ERA
Otoscope
ERL
Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
EWG
Laser, Ent Microsurgical Carbon-Dioxide
EWQ
Saw, Surgical, Ent (Electric Or Pneumatic)
EWY
Mediastinoscope, Surgical
JEI
Claw, Foreign Body, Bronchoscope (Non-Rigid)
JEJ
Tubing, Instrumentation, Bronchoscope (Brush Sheath A/O Aspirating)
JEK
Forceps, Biopsy, Bronchoscope (Rigid)
JEL
Curette, Biopsy, Bronchoscope (Rigid)
JYE
Chisel, Middle-Ear
JYF
Clamp, Ossicle Holding
JYG
Curette, Ear
JYH
Excavator, Ear
JYI
Gauge, Mastoid
JYJ
Gauge, Measuring
JYL
Hook, Microsurgical Ear
JYM
Inserter, Myringotomy Tube
JYN
Inserter, Sacculotomy Tack
JYO
Knife, Ear
JYP
Knife, Myringotomy
JYQ
Loop, Wire
JYR
Nipper, Malleus
JYS
Perforator, Ear-Lobe
JYT
Pick, Microsurgical Ear
JYW
Press, Vein
JYX
Punch, Attic
JYY
Rasp, Ear
JYZ
Rod, Measuring Ear
JZA
Rongeur, Mastoid
JZB
Scissors, Ear
JZC
Searcher, Mastoid
JZD
Snare, Ear
JZE
Spoon, Ear
JZF
Tube, Ear Suction
JZY
Knife, Laryngeal
JZZ
Saw, Laryngeal
KAA
Set, Laryngeal Injection
KAB
Trocar, Laryngeal
KAC
Tube, Laryngectomy
KAD
Elevator, Ent
KAE
Forceps, Ent
KAH
Microrule, Ent
KAI
Mirror, Ent
KAJ
Mobilizer, Ent
KAK
Probe, Ent
KAL
Retractor, Ent
KAO
Curette, Ethmoid
KAP
Curette, Nasal
KAQ
Gouge, Nasal, Ent
KAR
Irrigator, Sinus
KAS
Knife, Nasal
KAT
Perforator, Antrum
KAW
Punch, Antrum
KAX
Punch, Ethmoid
KAY
Punch, Nasal
KAZ
Rasp, Frontal-Sinus
KBA
Rasp, Nasal
KBB
Rongeur, Nasal
KBC
Saw, Nasal
KBD
Scissors, Nasal
KBE
Snare, Nasal
KBF
Trephine, Sinus
KBG
Trocar, Sinus
KBH
Adenotome
KBI
Bougie, Eustachian
KBJ
Curette, Adenoid
KBK
Curette, Salpingeal
KBL
Depressor, Metal Tongue, Surgical
KBM
Dissector, Tonsil
KBN
Gag, Mouth
KBO
Guillotine, Tonsil
KBP
Hook, Tonsil Suturing
KBQ
Knife, Tonsil
KBR
Needle, Tonsil Suturing
KBS
Punch, Adenoid
KBT
Punch, Tonsil
KBW
Screw, Oral
KBX
Screw, Tonsil
KBY
Set, Filliform, Eustachian
KBZ
Snare, Tonsil
KCA
Tonsillectome
KCB
Tube, Tonsil Suction
KCC
Bistoury, Tracheal
KCD
Bougie, Esophageal, Ent
KCF
Dilator, Esophageal, Ent
KCG
Dilator, Tracheal
KCH
Hook, Tracheal
KCI
Trocar, Tracheal
KTE
Trocar, Ent
KTF
Punch, Ent
KTG
Knife, Ent
KTI
Bronchoscope Accessory
KTR
Tube, Aspirating, Bronchoscope, Rigid
LJW
Tracheotome
LMS
Laser, Microsurgical Argon, For Uses Other Than Otology, Including Laryngology & General Use In Otolaryngology
LRC
Instrument, Ent Manual Surgical
K
23
0258
BB 8 Sinus Dilation Kit
K
21
2774
VenSure LightGuide
K
20
1398
SINUSPRIME Dilation System
K
20
1115
Next Generation Balloon Dilation System
K
20
1472
VenSure Balloon Device, VenSure Nav Balloon Device
K
18
1546
Dillard Nasal Balloon Catheter
K
19
0525
RELIEVA ULTIRRA Sinus Balloon Catheter
K
18
1838
Sinusway Dilation System
K
17
2737
MESIRE - Balloon Sinus Dilatation System
K
17
1687
Relieva SpinPlus Nav Balloon Sinuplasty System
K
16
1698
Relieva UltirraNav Sinus Balloon Catheter
K
16
0770
Vent-Os Sinus Dilation family
K
15
3341
Relieva Scout Multi-Sinus Dilation System
K
15
2121
NuVent EM Sinus Dilation System
K
15
2435
PassAssist LED Light Fiber
K
15
2434
XprESS Multi-Sinus Dilation System
K
14
3738
DSS Sinusplasty Balloon Catheter
K
14
3541
Relieva SpinPlus Balloon Sinuplasty System
K
15
0172
ACCLARENT SE Inflation Device
K
14
2252
XprESS Multi-Sinus Dilation Tool
K
14
1916
PATHASSIST LED LIGHT FIBER
K
14
0160
RELIEVA SCOUT SINUS DILATION SYSTEM
K
13
3563
PATHASSIST LIGHT SEEKER
K
13
0736
BLOM-SINGER ADJUSTABLE BI-FIANGED FISTULA PROSTHESIS
K
13
3016
VENT-OS SINUS DILATION SYSTEM
K
13
2297
EM SINUS DILATION SYSTEM
K
13
2440
XPRESS MULTI-SINUS DILATION TOOL
K
13
1709
SINUS DILATION SYSTEM WITH CANNULATED INSTRUMENT
K
13
0503
PATHASSIST LED LIGHT FIBER
K
12
0280
RELIEVA SEEKER BALLOON SINUPLASTY SYSTEM
K
12
1351
SINUS DILATION SYSTEM
K
12
1943
XPRESS MULTI-SINUS DILATION TOOL
K
12
1174
XPRESS MULTI-SINUS DILATION TOOL
K
12
0962
PATHASSIST LIGHT FIBER
K
12
0735
PATHASSIT LIGHT SEEKER
K
11
3522
PATHASSIST LIGHT SEEKER
K
11
2506
XPRESS MULTI-SINUS DILATION TOOL
K
11
1875
RELIEVA SPIN SINUS DILATION SYSTEM
K
11
1763
PATHASSIST LIGHT FIBER
K
11
1254
RELIEVA SOLO ELITE SINUS BALLOON CATHETER
K
11
0739
ENTELLUS MEDICAL SINUS GUIDEWIRE
K
11
0158
ILLUMINATING SINUS SEEKER
K
10
2003
XPRESS BALLOON DEVICE
K
09
3007
ENTELLUS MEDICAL BALLOON DEVICE
K
09
1681
FINESS SINUS TREATMENT SYSTEM (ACCESS SHEATH COMPONENT)
K
08
1542
MODIFICATION TO ENTELLUS MEDICAL RS-SERIES SYSTEM
K
07
2302
ENTELLUS MEDICAL RS-SERIES SYSTEM
K
06
1903
RELIEVA SINUS BALLOON CATHETER
K
05
2198
RELIEVA SINUS BALLOON INFLATION DEVICE
K
04
3527
RELIEVA SINUS BALLOON DILATION CATHETER
K
99
0366
EXMOOR SUCTION CLEARANCE KIT
K
97
0018
FAST TRACT TRANSTRACHEAL PROCEDURE KIT
K
94
2745
EXMOOR SINGLE USE MYRINGOTOMES
K
94
2746
SUCKER ENDS (ZOELLNER)
K
94
2064
DISPOSABLE NASAL RONGEUR
K
94
2063
DISPOSABLE NASAL SCISSOR
K
94
2065
DISPOSABLE ENT PUNCH
K
93
3770
FORCEPS, ENT INSTR, ENT MANUAL SURG RETRACT/ALL TYPE
K
93
1793
SYMBIOSIS ENT SURGICAL INSTRUMENTS
K
93
0292
HOUSE-BELLUCCI ALLIGATOR SCISSORS
K
92
0988
ATMOS MIRROR WARMER
K
89
2504
'EXMOOR' SINGLE USE SUCTION TUBE
K
88
4631
FLEXIBLE ENDOSCOPE 91-8200(90) AND 91-82100(135)
K
87
3044
POREX OTOLOGY INSTRUMENTS
K
86
4938
'EXMOOR' MOFFAT-ROBINSON BONE PATE COLLECTOR
LXR
Laser, Microsurgical Argon, For Use In Otology
LYA
Splint, Intranasal Septal
MMO
Tray, Surgical, Ent
MQW
Transilluminator, Fiber Optic
MXP
Bone Particle Collector
NLB
Trocar, Tracheal, Laryngeal, Sinus, Reprocessed
NLE
Forceps, Biopsy, Bronchoscope (Non-Rigid), Reprocessed
NLY
Microdebrider, Ent, High Speed, Single Use, Reprocessed
NLZ
Bur, Ent, Diamond Coated, Single Use, Reprocessed
OGR
Ear, Nose, And Throat Surgical Tray
OGU
Pierced Ear/Entry Cleaning Tray
PNZ
Eustachian Tube Balloon Dilation Device
QGK
Balloon, Nasal Airway
QJL
Splint, Intranasal Septal, Cber Led
QNW
Reprocessed Bronchoscope
QQH
Powered Insertion System For A Cochlear Implant Electrode Array
OLL
Septal Stapler/Absorbable Staples
SBS
Laryngeal Injection Set With Led Light
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—surgical-devices
/
LRC
/
K091681
View Source
FINESS SINUS TREATMENT SYSTEM (ACCESS SHEATH COMPONENT)
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K091681
510(k) Type
Special
Applicant
Entellus Medical, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
7/8/2009
Days to Decision
28 days
Submission Type
Summary