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
EPF
Hearing Aid, Group And Auditory Trainer
2
Product Code
NEA
Cement, Ear, Nose And Throat
2
Product Code
ESD
Hearing Aid, Air Conduction
1
Product Code
ESE
Larynx, Artificial (Battery-Powered)
1
Product Code
ESH
Polymer, Ent Synthetic-Pife, Silicon Elastomer, Polyethylene, Polyurethane
2
Product Code
ESX
Tack, Sacculotomy (Cody Tack)
2
Product Code
ESZ
Tube, Shunt, Endolymphatic
2
Product Code
ETA
Replacement, Ossicular Prosthesis, Total
2
Product Code
ETB
Prosthesis, Partial Ossicular Replacement
2
Product Code
ETC
Mold, Middle-Ear
2
Product Code
ETD
Tube, Tympanostomy
2
Product Code
K
23
2702
Solo+ Tympanostomy Tube Device (TTD)
2
Cleared 510(K)
K
23
3658
Biowy Tym Tube (TT)
2
Cleared 510(K)
K
23
2059
Tympanostomy Tubes
2
Cleared 510(K)
K
22
1254
Hummingbird Tympanostomy Tube System
2
Cleared 510(K)
K
20
0952
Hummingbird Tympanostomy Tube System
2
Cleared 510(K)
K
17
1239
TULA Tube Delivery System
2
Cleared 510(K)
K
15
1830
Hummingbird Tympanostomy Tube
2
Cleared 510(K)
K
15
1067
Ventilation (Tympanostomy) Tubes
2
Cleared 510(K)
K
14
2282
HUMMINGBIRD(TM) TYMPANOSTOMY TUBE SYSTEM (TTS)
2
Cleared 510(K)
K
13
3921
PRECEPTIS TYMPANOSTOMY TUBE INSERTER
2
Cleared 510(K)
K
10
3595
ACCLARENT TYMPANOSTOMY TUBE AND TYMPANOSTOMY TUBE DELIVERY SYSTEM
2
Cleared 510(K)
K
08
2188
TYMPANOSTOMY TUBE
2
Cleared 510(K)
K
07
1150
TROCAR VENTILATION TUBE/WITH TROCAR TIP, TROCAR HANDLE, MODEL 1015 074, 1015 076, 1015 075, 1015 077, W/ RETENTION WIRE
2
Cleared 510(K)
K
07
1178
OTOMEDICS SOFT TYMPANOSTOMY TUBE
2
Cleared 510(K)
K
06
2672
GRACE MEDICAL PC COATED TYMPANOSTOMY TUBES
2
Cleared 510(K)
K
06
2385
BLUE PTFE (FLUOROPLASTIC) VENTILATION TUBES
2
Cleared 510(K)
K
06
1058
NEOZOLINE VENTILATION TUBES
2
Cleared 510(K)
K
01
1383
MICRODOSE CATH, MODELS 90121-201, -202, -203
2
Cleared 510(K)
K
00
0801
PC COATED FLUOROPLASTIC VENT TUBES
2
Cleared 510(K)
K
99
2222
FLUOROPLASTIC VENTILATION TUBES
2
Cleared 510(K)
K
99
1670
SILVERSTEIN MICROWICK
2
Cleared 510(K)
K
98
0828
EXMOOR MYRINGOTOMY KIT
2
Cleared 510(K)
K
98
1575
TYMPANOSTOMY TUBE
2
Cleared 510(K)
K
97
4008
PFLEIDERER'S INTRATYMPANIC CATHETER
2
Cleared 510(K)
K
97
3740
ROUND WINDOW E-CATH
2
Cleared 510(K)
K
97
4007
SHAH PERMAVENT
2
Cleared 510(K)
K
97
3226
TUBINGEN TYMPANIC VENTILATION TUBE, TYMPANIC VENTILATION TUBES WITH ENE/S, DIABOLO TYMPANIC VENTILATION TUBE, MINIMAL T)
2
Cleared 510(K)
K
97
2126
MYRINGOTOMY TUBE
2
Cleared 510(K)
K
97
2400
MYRINGOTOMY TUBE - BOBBIN WITH TAB
2
Cleared 510(K)
K
97
1943
MYRINGOTOMY TUBE
2
Cleared 510(K)
K
97
1454
TYMPANOSTOMY VENTILATION TUBE
2
Cleared 510(K)
K
97
1124
TM MICRO-CATHETERS
2
Cleared 510(K)
K
96
5115
ROUND WINDOW CATH
2
Cleared 510(K)
K
96
3727
HOFFMAN H/A COATED LONG-TERM VENTILATION TUBE WITH LINER
2
Cleared 510(K)
K
96
1873
ACTIVENT ANTIMICROBIAL VENTILATION TUBES
2
Cleared 510(K)
K
96
1945
TYMPANOSTOMY VENTILATION TUBE
2
Cleared 510(K)
K
96
0742
TYMPANOSTOMY VENTILATION TUBE
2
Cleared 510(K)
K
96
0477
VENTILATION TUBES
2
Cleared 510(K)
K
95
5616
MISTEN MEDICAL REUTER BOBBIN STYLE VENT TUBE
2
Cleared 510(K)
K
95
5447
TYMPANOSTOMY TUBE
2
Cleared 510(K)
K
95
4795
AT2 & DOYLE STYLE (C-FLEX) VENT TUBES
2
Cleared 510(K)
K
95
3802
TYMPANOSTOMY TUBE
2
Cleared 510(K)
K
95
3993
TYMPASNOSTOMY TUBE
2
Cleared 510(K)
K
94
1407
TYMPANOSTOMY (VENTILATION) TUBE
2
Cleared 510(K)
K
94
3325
TYMPANOSTOMY TUBE
2
Cleared 510(K)
K
94
3848
COLLAR BUTTON VENTURI VENT TUBE
2
Cleared 510(K)
K
94
3849
GROMMENT STYLE VENTURI TUBE
2
Cleared 510(K)
K
94
3847
BOBBIN STYLE VENTURI VENT TUBE
2
Cleared 510(K)
K
94
3281
POLYETHYLENE VENT TUBES
2
Cleared 510(K)
K
94
3190
C-FLEX VENT TUBES
2
Cleared 510(K)
K
93
6275
TYMPOVENT
2
Cleared 510(K)
K
93
2166
SILICONE TYMPANOSTOMY TUBES
2
Cleared 510(K)
K
92
3353
VENTILATION TUBES W/ HYDROGEL COATING
2
Cleared 510(K)
K
92
6462
BEL-AIR VENTILATION TUBE
2
Cleared 510(K)
K
92
3887
JACK'S VENT TUBES
2
Cleared 510(K)
K
92
1923
TITANIUM VENTILATION TUBES
2
Cleared 510(K)
K
91
1580
DONALDSON/SHEPARDS DR/COLLAR/SHAH VENT-MINI TUBES
2
Cleared 510(K)
K
91
0618
SUH VENT TUBE
2
Cleared 510(K)
K
90
4592
BOBBIN STYLE VENTURI
2
Cleared 510(K)
K
90
4597
GROMMET STYLE VENTURI
2
Cleared 510(K)
K
90
4594
COLLAR BUTTON STYLE VENTURI
2
Cleared 510(K)
K
90
3285
MICRO BRIGHT VENTILATION TUBES
2
Cleared 510(K)
K
90
0267
JAHN VENTILATION TUBE
2
Cleared 510(K)
K
89
5242
PAPPAS TRI-FLANGE VENTILATION TUBE
2
Cleared 510(K)
K
88
3667
DONALDSON VENTILATION TUBES PT. # AG/S9
2
Cleared 510(K)
K
88
2689
PUNCH MYRINGOTOMY SYSTEM
2
Cleared 510(K)
K
87
0877
BIO-VENT REUTER BOBBIN TUBE
2
Cleared 510(K)
K
87
1035
'EXMOOR' T-TUBE
2
Cleared 510(K)
K
87
0129
VENTILATION TUBES WITH HYDROGEL COATING
2
Cleared 510(K)
K
85
3641
GODDE T-TUBE BLUE SILICONE TYMPANOSTOMY TUBE
2
Cleared 510(K)
K
85
2387
GOODE T-TUBE WHITE SILICONE TYMPANOSTOMY TUBE
2
Cleared 510(K)
K
83
3246
TYMPANOSTOMY TUBES-VARIOUS
2
Cleared 510(K)
K
84
2637
UNIFLOW VENT TUBE
2
Cleared 510(K)
K
83
3910
TSH RIA
2
Cleared 510(K)
K
82
3910
DONALDSON VENT TUBE
2
Cleared 510(K)
K
83
3909
VENTRESCREEN BETA-HCG ENZYME IMMUNO
2
Cleared 510(K)
K
83
2362
DONALDSON-TYPE VENT TUBE
2
Cleared 510(K)
K
83
2361
CONCEPT T-TUBE
2
Cleared 510(K)
K
83
0584
SOILEAU TYTAN BOBBIN VENT TUBE
2
Cleared 510(K)
K
82
3909
T-TUBE VENT TUBE
2
Cleared 510(K)
K
83
0228
OTOLOGICAL VENTILATION TUBES-VARIOUS
2
Cleared 510(K)
K
83
0085
COLLAR BUTTON VENT TUBE
2
Cleared 510(K)
K
82
3908
GROMMET VENT TUBE
2
Cleared 510(K)
K
82
3907
COLLAR BUTTON VENT TUBE
2
Cleared 510(K)
K
82
2017
TYMPANOSTOMY TUBES & VARIOUS TYPES
2
Cleared 510(K)
K
82
2376
TYTAN REUTER BOBBIN VENT TUBE
2
Cleared 510(K)
K
82
2375
ARMSTRONG V VENT TUBE
2
Cleared 510(K)
K
82
2366
TYTAN GROMMET VENT TUBE, .040
2
Cleared 510(K)
K
82
0510
TYMPANOSTOMY TUBES (VARIOUS MODELS
2
Cleared 510(K)
K
82
0362
REUTER BOBBIN VENTILA. TUBE-TITANIUM
2
Cleared 510(K)
K
81
3616
TEKNA MED MYRINGOTOMY DISPOS-OTO KIT
2
Cleared 510(K)
K
81
2459
EXMOOR AURAL GROMMET AG/TI
2
Cleared 510(K)
K
81
2460
VARIOUS AURAL GROMMETS
2
Cleared 510(K)
K
81
1698
CARL ZEISS INN MYRINGOTOMY TUBE LINE
2
Cleared 510(K)
K
81
0701
EXMOOR AURAL GROMMET
2
Cleared 510(K)
K
81
0702
EXMOOR AURAL GROMMET AG/T2L
2
Cleared 510(K)
K
81
0703
EXMOOR AURAL GROMMET AG/T2
2
Cleared 510(K)
K
81
0704
EXMOOR AURAL GROMMET AG/T3
2
Cleared 510(K)
K
81
0705
EXMOOR AURAL GROMMET AG/T4
2
Cleared 510(K)
K
81
0706
EXMOOR AURAL GROMMET AG/T5
2
Cleared 510(K)
K
80
2638
OTOLOGICAL VENTILATION TUBES
2
Cleared 510(K)
K
80
2587
OTOLOGICAL VENTILATION TUBES
2
Cleared 510(K)
K
80
0728
PAPARELL TYPE 2, BIOLITE COATED SILI-
2
Cleared 510(K)
K
80
0727
GOODE T-TUBE, BIOLITE COATED SILICONE/TU
2
Cleared 510(K)
K
79
1680
POPE UMBRELLA TUBE
2
Cleared 510(K)
K
79
0216
VENTILATION TUBE, SHEEHY COLLAT
2
Cleared 510(K)
K
78
1258
VENTILATION TUBE. SILI. DONALDSON TYPE
2
Cleared 510(K)
K
78
1260
VENTILATION TUBE SILICONE PAPARELLA TYPE
2
Cleared 510(K)
K
78
1259
VENTILATION TUBE TEFLON SHEPARD TYPE
2
Cleared 510(K)
K
78
1257
VENTILATION TUBE SILI. SHEPPARD TYPE
2
Cleared 510(K)
K
78
0956
OTOLOGICAL VENTILATION TUBES
2
Cleared 510(K)
K
77
2066
PULLEN PLASTIC-PORE PLUGS
2
Cleared 510(K)
K
76
0439
PLASTI-PORE BOBBIN DRAIN TUBE, OTOLOGY
2
Cleared 510(K)
K
76
0438
SPOON-BOBBIN DRAIN TUBE W/ WIRE, OTOLOGY
2
Cleared 510(K)
ETW
Calibrator, Hearing Aid / Earphone And Analysis Systems
2
Product Code
EWL
Prosthesis, Laryngeal (Taub)
2
Product Code
FWN
Prosthesis, Larynx (Stents And Keels)
2
Product Code
JAZ
Prosthesis, Facial, Mandibular Implant
2
Product Code
JOF
Polymer, Ent Synthetic, Porous Polyethylene
2
Product Code
JXS
Block, Cutting, Ent, Sterile
1
Product Code
JXT
Crimper, Wire, Ent, Sterile
1
Product Code
JXW
Die, Wire Bending, Ent, Sterile
1
Product Code
JXX
Forceps, Wire Closure, Ent, Sterile
1
Product Code
JXY
Jig, Piston Cutting, Ent, Sterile
1
Product Code
JXZ
Punch, Gelfoam, Sterile
1
Product Code
JYA
Scissors, Wire Cutting, Ent, Sterile
1
Product Code
JYB
Vise, Ossicular Finger, Sterile
1
Product Code
KHJ
Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)
2
Product Code
KHL
Hearing Aid, Master
2
Product Code
KLW
Masker, Tinnitus
2
Product Code
KLZ
Tube, Shunt, Endolymphatic With Valve
2
Product Code
KQL
Tube, Tympanostomy With Semi-Permeable Membrane
2
Product Code
LBL
Tube, Tympanostomy, Porous Polyethylene
2
Product Code
LBM
Porous Polyethylene Ossicular Replacement
2
Product Code
LBN
Replacement, Total Ossicular, Prosthesis, Porous, Polyethylene
2
Product Code
LBP
Replacement, Ossicular (Stapes) Using Absorbable Gelatin Material
2
Product Code
LDG
Kit, Earmold, Impression
1
Product Code
LRB
Face Plate Hearing Aid
1
Product Code
LRE
Instrument, Prosthesis Modification For Ossicular Replacement Surgery, Sterile
1
Product Code
LWF
Dilator, Nasal
1
Product Code
LXB
Hearing Aid, Bone Conduction
2
Product Code
LZI
Device, Assistive Listening
2
Product Code
MAH
Hearing Aid, Bone Conduction, Implanted
2
Product Code
MCK
Device, Voice Amplification
2
Product Code
MIX
System, Vocal Cord Medialization
2
Product Code
NHB
Polymer, Ear, Nose And Throat, Synthetic, Absorbable
2
Product Code
NIX
Hearing Aid, Air Conduction, Transcutaneous System
2
Product Code
NNN
Crimper, Wire, Ent, Non-Sterile
1
Product Code
NNO
Jig, Piston Cutting, Ent, Non-Sterile
1
Product Code
NNP
Die, Wire Bending, Ent, Non-Sterile
1
Product Code
NNQ
Forceps, Wire Closure, Ent, Non-Sterile
1
Product Code
NNR
Block, Cutting, Ent, Non-Sterile
1
Product Code
NNS
Instrument, Prosthesis Modification For Ossicular Replacement Surgery, Non-Sterile
1
Product Code
NNT
Punch, Gelfoam, Non-Sterile
1
Product Code
NNU
Scissors, Wire Cutting, Ent, Non-Sterile
1
Product Code
NNV
Vise, Ossicular Finger, Non-Sterile
1
Product Code
OGS
Myringotomy Procedure Kit
2
Product Code
OSM
Hearing Aid, Air Conduction With Wireless Technology
2
Product Code
PFO
Active Implantable Bone Conduction Hearing System
2
Product Code
PLK
Tympanic Membrane Direct Contact Hearing Aid
2
Product Code
QDD
Self-Fitting Air-Conduction Hearing Aid
2
Product Code
QUF
Hearing Aid, Air-Conduction, Over The Counter
1
Product Code
QUG
Hearing Aid, Air-Conduction With Wireless Technology, Over The Counter
2
Product Code
QUH
Self-Fitting Air-Conduction Hearing Aid, Over The Counter
2
Product Code
Subpart E—Neurological Surgical Devices
CFR Sub-Part
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
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Immunology
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Microbiology
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Neurology
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Obstetrical and Gynecological
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Ophthalmic
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Orthopedic
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Pathology
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Physical Medicine
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Medical Genetics
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Review Panel
Last synced on 16 August 2024 at 11:05 pm
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subpart-d—prosthetic-devices
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ETD
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K852387
View Source
GOODE T-TUBE WHITE SILICONE TYMPANOSTOMY TUBE
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K852387
510(k) Type
Traditional
Applicant
XOMED, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
1/6/1986
Days to Decision
215 days
FDA Browser
by
Innolitics
Anesthesiology
Cardiovascular
Chemistry
Dental
Ear, Nose, Throat
Miscellaneous
Subpart B—Diagnostic Devices
Subpart D—Prosthetic Devices
EPF
Hearing Aid, Group And Auditory Trainer
NEA
Cement, Ear, Nose And Throat
ESD
Hearing Aid, Air Conduction
ESE
Larynx, Artificial (Battery-Powered)
ESH
Polymer, Ent Synthetic-Pife, Silicon Elastomer, Polyethylene, Polyurethane
ESX
Tack, Sacculotomy (Cody Tack)
ESZ
Tube, Shunt, Endolymphatic
ETA
Replacement, Ossicular Prosthesis, Total
ETB
Prosthesis, Partial Ossicular Replacement
ETC
Mold, Middle-Ear
ETD
Tube, Tympanostomy
K
23
2702
Solo+ Tympanostomy Tube Device (TTD)
K
23
3658
Biowy Tym Tube (TT)
K
23
2059
Tympanostomy Tubes
K
22
1254
Hummingbird Tympanostomy Tube System
K
20
0952
Hummingbird Tympanostomy Tube System
K
17
1239
TULA Tube Delivery System
K
15
1830
Hummingbird Tympanostomy Tube
K
15
1067
Ventilation (Tympanostomy) Tubes
K
14
2282
HUMMINGBIRD(TM) TYMPANOSTOMY TUBE SYSTEM (TTS)
K
13
3921
PRECEPTIS TYMPANOSTOMY TUBE INSERTER
K
10
3595
ACCLARENT TYMPANOSTOMY TUBE AND TYMPANOSTOMY TUBE DELIVERY SYSTEM
K
08
2188
TYMPANOSTOMY TUBE
K
07
1150
TROCAR VENTILATION TUBE/WITH TROCAR TIP, TROCAR HANDLE, MODEL 1015 074, 1015 076, 1015 075, 1015 077, W/ RETENTION WIRE
K
07
1178
OTOMEDICS SOFT TYMPANOSTOMY TUBE
K
06
2672
GRACE MEDICAL PC COATED TYMPANOSTOMY TUBES
K
06
2385
BLUE PTFE (FLUOROPLASTIC) VENTILATION TUBES
K
06
1058
NEOZOLINE VENTILATION TUBES
K
01
1383
MICRODOSE CATH, MODELS 90121-201, -202, -203
K
00
0801
PC COATED FLUOROPLASTIC VENT TUBES
K
99
2222
FLUOROPLASTIC VENTILATION TUBES
K
99
1670
SILVERSTEIN MICROWICK
K
98
0828
EXMOOR MYRINGOTOMY KIT
K
98
1575
TYMPANOSTOMY TUBE
K
97
4008
PFLEIDERER'S INTRATYMPANIC CATHETER
K
97
3740
ROUND WINDOW E-CATH
K
97
4007
SHAH PERMAVENT
K
97
3226
TUBINGEN TYMPANIC VENTILATION TUBE, TYMPANIC VENTILATION TUBES WITH ENE/S, DIABOLO TYMPANIC VENTILATION TUBE, MINIMAL T)
K
97
2126
MYRINGOTOMY TUBE
K
97
2400
MYRINGOTOMY TUBE - BOBBIN WITH TAB
K
97
1943
MYRINGOTOMY TUBE
K
97
1454
TYMPANOSTOMY VENTILATION TUBE
K
97
1124
TM MICRO-CATHETERS
K
96
5115
ROUND WINDOW CATH
K
96
3727
HOFFMAN H/A COATED LONG-TERM VENTILATION TUBE WITH LINER
K
96
1873
ACTIVENT ANTIMICROBIAL VENTILATION TUBES
K
96
1945
TYMPANOSTOMY VENTILATION TUBE
K
96
0742
TYMPANOSTOMY VENTILATION TUBE
K
96
0477
VENTILATION TUBES
K
95
5616
MISTEN MEDICAL REUTER BOBBIN STYLE VENT TUBE
K
95
5447
TYMPANOSTOMY TUBE
K
95
4795
AT2 & DOYLE STYLE (C-FLEX) VENT TUBES
K
95
3802
TYMPANOSTOMY TUBE
K
95
3993
TYMPASNOSTOMY TUBE
K
94
1407
TYMPANOSTOMY (VENTILATION) TUBE
K
94
3325
TYMPANOSTOMY TUBE
K
94
3848
COLLAR BUTTON VENTURI VENT TUBE
K
94
3849
GROMMENT STYLE VENTURI TUBE
K
94
3847
BOBBIN STYLE VENTURI VENT TUBE
K
94
3281
POLYETHYLENE VENT TUBES
K
94
3190
C-FLEX VENT TUBES
K
93
6275
TYMPOVENT
K
93
2166
SILICONE TYMPANOSTOMY TUBES
K
92
3353
VENTILATION TUBES W/ HYDROGEL COATING
K
92
6462
BEL-AIR VENTILATION TUBE
K
92
3887
JACK'S VENT TUBES
K
92
1923
TITANIUM VENTILATION TUBES
K
91
1580
DONALDSON/SHEPARDS DR/COLLAR/SHAH VENT-MINI TUBES
K
91
0618
SUH VENT TUBE
K
90
4592
BOBBIN STYLE VENTURI
K
90
4597
GROMMET STYLE VENTURI
K
90
4594
COLLAR BUTTON STYLE VENTURI
K
90
3285
MICRO BRIGHT VENTILATION TUBES
K
90
0267
JAHN VENTILATION TUBE
K
89
5242
PAPPAS TRI-FLANGE VENTILATION TUBE
K
88
3667
DONALDSON VENTILATION TUBES PT. # AG/S9
K
88
2689
PUNCH MYRINGOTOMY SYSTEM
K
87
0877
BIO-VENT REUTER BOBBIN TUBE
K
87
1035
'EXMOOR' T-TUBE
K
87
0129
VENTILATION TUBES WITH HYDROGEL COATING
K
85
3641
GODDE T-TUBE BLUE SILICONE TYMPANOSTOMY TUBE
K
85
2387
GOODE T-TUBE WHITE SILICONE TYMPANOSTOMY TUBE
K
83
3246
TYMPANOSTOMY TUBES-VARIOUS
K
84
2637
UNIFLOW VENT TUBE
K
83
3910
TSH RIA
K
82
3910
DONALDSON VENT TUBE
K
83
3909
VENTRESCREEN BETA-HCG ENZYME IMMUNO
K
83
2362
DONALDSON-TYPE VENT TUBE
K
83
2361
CONCEPT T-TUBE
K
83
0584
SOILEAU TYTAN BOBBIN VENT TUBE
K
82
3909
T-TUBE VENT TUBE
K
83
0228
OTOLOGICAL VENTILATION TUBES-VARIOUS
K
83
0085
COLLAR BUTTON VENT TUBE
K
82
3908
GROMMET VENT TUBE
K
82
3907
COLLAR BUTTON VENT TUBE
K
82
2017
TYMPANOSTOMY TUBES & VARIOUS TYPES
K
82
2376
TYTAN REUTER BOBBIN VENT TUBE
K
82
2375
ARMSTRONG V VENT TUBE
K
82
2366
TYTAN GROMMET VENT TUBE, .040
K
82
0510
TYMPANOSTOMY TUBES (VARIOUS MODELS
K
82
0362
REUTER BOBBIN VENTILA. TUBE-TITANIUM
K
81
3616
TEKNA MED MYRINGOTOMY DISPOS-OTO KIT
K
81
2459
EXMOOR AURAL GROMMET AG/TI
K
81
2460
VARIOUS AURAL GROMMETS
K
81
1698
CARL ZEISS INN MYRINGOTOMY TUBE LINE
K
81
0701
EXMOOR AURAL GROMMET
K
81
0702
EXMOOR AURAL GROMMET AG/T2L
K
81
0703
EXMOOR AURAL GROMMET AG/T2
K
81
0704
EXMOOR AURAL GROMMET AG/T3
K
81
0705
EXMOOR AURAL GROMMET AG/T4
K
81
0706
EXMOOR AURAL GROMMET AG/T5
K
80
2638
OTOLOGICAL VENTILATION TUBES
K
80
2587
OTOLOGICAL VENTILATION TUBES
K
80
0728
PAPARELL TYPE 2, BIOLITE COATED SILI-
K
80
0727
GOODE T-TUBE, BIOLITE COATED SILICONE/TU
K
79
1680
POPE UMBRELLA TUBE
K
79
0216
VENTILATION TUBE, SHEEHY COLLAT
K
78
1258
VENTILATION TUBE. SILI. DONALDSON TYPE
K
78
1260
VENTILATION TUBE SILICONE PAPARELLA TYPE
K
78
1259
VENTILATION TUBE TEFLON SHEPARD TYPE
K
78
1257
VENTILATION TUBE SILI. SHEPPARD TYPE
K
78
0956
OTOLOGICAL VENTILATION TUBES
K
77
2066
PULLEN PLASTIC-PORE PLUGS
K
76
0439
PLASTI-PORE BOBBIN DRAIN TUBE, OTOLOGY
K
76
0438
SPOON-BOBBIN DRAIN TUBE W/ WIRE, OTOLOGY
ETW
Calibrator, Hearing Aid / Earphone And Analysis Systems
EWL
Prosthesis, Laryngeal (Taub)
FWN
Prosthesis, Larynx (Stents And Keels)
JAZ
Prosthesis, Facial, Mandibular Implant
JOF
Polymer, Ent Synthetic, Porous Polyethylene
JXS
Block, Cutting, Ent, Sterile
JXT
Crimper, Wire, Ent, Sterile
JXW
Die, Wire Bending, Ent, Sterile
JXX
Forceps, Wire Closure, Ent, Sterile
JXY
Jig, Piston Cutting, Ent, Sterile
JXZ
Punch, Gelfoam, Sterile
JYA
Scissors, Wire Cutting, Ent, Sterile
JYB
Vise, Ossicular Finger, Sterile
KHJ
Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)
KHL
Hearing Aid, Master
KLW
Masker, Tinnitus
KLZ
Tube, Shunt, Endolymphatic With Valve
KQL
Tube, Tympanostomy With Semi-Permeable Membrane
LBL
Tube, Tympanostomy, Porous Polyethylene
LBM
Porous Polyethylene Ossicular Replacement
LBN
Replacement, Total Ossicular, Prosthesis, Porous, Polyethylene
LBP
Replacement, Ossicular (Stapes) Using Absorbable Gelatin Material
LDG
Kit, Earmold, Impression
LRB
Face Plate Hearing Aid
LRE
Instrument, Prosthesis Modification For Ossicular Replacement Surgery, Sterile
LWF
Dilator, Nasal
LXB
Hearing Aid, Bone Conduction
LZI
Device, Assistive Listening
MAH
Hearing Aid, Bone Conduction, Implanted
MCK
Device, Voice Amplification
MIX
System, Vocal Cord Medialization
NHB
Polymer, Ear, Nose And Throat, Synthetic, Absorbable
NIX
Hearing Aid, Air Conduction, Transcutaneous System
NNN
Crimper, Wire, Ent, Non-Sterile
NNO
Jig, Piston Cutting, Ent, Non-Sterile
NNP
Die, Wire Bending, Ent, Non-Sterile
NNQ
Forceps, Wire Closure, Ent, Non-Sterile
NNR
Block, Cutting, Ent, Non-Sterile
NNS
Instrument, Prosthesis Modification For Ossicular Replacement Surgery, Non-Sterile
NNT
Punch, Gelfoam, Non-Sterile
NNU
Scissors, Wire Cutting, Ent, Non-Sterile
NNV
Vise, Ossicular Finger, Non-Sterile
OGS
Myringotomy Procedure Kit
OSM
Hearing Aid, Air Conduction With Wireless Technology
PFO
Active Implantable Bone Conduction Hearing System
PLK
Tympanic Membrane Direct Contact Hearing Aid
QDD
Self-Fitting Air-Conduction Hearing Aid
QUF
Hearing Aid, Air-Conduction, Over The Counter
QUG
Hearing Aid, Air-Conduction With Wireless Technology, Over The Counter
QUH
Self-Fitting Air-Conduction Hearing Aid, Over The Counter
Subpart E—Neurological Surgical Devices
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-d—prosthetic-devices
/
ETD
/
K852387
View Source
GOODE T-TUBE WHITE SILICONE TYMPANOSTOMY TUBE
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K852387
510(k) Type
Traditional
Applicant
XOMED, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
1/6/1986
Days to Decision
215 days