FDA Browser
by
Innolitics
Anesthesiology
Review Panel
Miscellaneous
Miscellaneous
Subpart B—Cardiovascular Diagnostic Devices
CFR Sub-Part
Subpart B—Diagnostic Devices
CFR Sub-Part
Subpart C—Cardiovascular Monitoring Devices
CFR Sub-Part
Subpart C—Monitoring Devices
CFR Sub-Part
Subpart D—Prosthetic Devices
CFR Sub-Part
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
BRW
Protector, Dental
1
Product Code
BSF
Absorber, Carbon-Dioxide
1
Product Code
BSJ
Mask, Gas, Anesthetic
1
Product Code
BSK
Cuff, Tracheal Tube, Inflatable
2
Product Code
BSN
Filter, Conduction, Anesthetic
2
Product Code
BSO
Catheter, Conduction, Anesthetic
2
Product Code
BSP
Needle, Conduction, Anesthetic (W/Wo Introducer)
2
Product Code
BSR
Stylet, Tracheal Tube
1
Product Code
BSZ
Gas-Machine, Anesthesia
2
Product Code
BTB
Hook, Ether
1
Product Code
BTC
Bag, Reservoir
1
Product Code
BTK
Strap, Head, Gas Mask
1
Product Code
BTL
Ventilator, Emergency, Powered (Resuscitator)
2
Product Code
BTM
Ventilator, Emergency, Manual (Resuscitator)
2
Product Code
BTO
Tube, Tracheostomy (W/Wo Connector)
2
Product Code
BTP
Dropper, Ether
1
Product Code
BTQ
Airway, Nasopharyngeal
1
Product Code
BTR
Tube, Tracheal (W/Wo Connector)
2
Product Code
K
23
3341
Shiley™ Oral/Nasal Endotracheal Tube Intermediate Cuff, Non-DEHP (87430, 87435, 87440, 87445, 87450, 87455, 87460, 87465, 87470, 87475, 87480, 87485, 87490, 87495, 87410)
2
Cleared 510(K)
K
22
3130
Shiley™ Pediatric Oral/Nasal Endotracheal Tube with TaperGuard™ Cuff, Non DEHP (86125, 86130, 86135, 86140, 86145, 86150, 86155, 86160)
2
Cleared 510(K)
K
21
1543
Wei Nasal Jet Tube
2
Cleared 510(K)
K
21
3028
Tenax Laser Resistant Endotracheal Tube
2
Cleared 510(K)
K
20
0761
Tenax Laser Resistant Endotracheal Tube
2
Cleared 510(K)
K
19
2120
Venner PneuX™ ETT (Endotracheal Tube) 6 mm, Venner PneuX™ ETT (Endotracheal Tube) 7 mm, Venner PneuX™ ETT (Endotracheal Tube) 8 mm, Venner PneuX™ ETT (Endotracheal Tube) 9 mm
2
Cleared 510(K)
K
19
0878
Trach- Vac Endotracheal Tube (SFTVPU) Subglottic Suction Tube with Salter Flex-Tip and Salter ThinCuff, Trach- Vac Endotracheal Tube (SFTVVC) Subglottic Suction Tube with Salter Flex-Tip and Salter ThinCuff
2
Cleared 510(K)
K
18
2739
Endotracheal Tube with Evacuation Lumen
2
Cleared 510(K)
K
19
2324
Sheridan Spiral-Flex Endotracheal Tubes
2
Cleared 510(K)
K
19
0630
SolidAIRity III Airway Stabilization System
2
Cleared 510(K)
K
19
0213
Yikang Endotracheal Tube
2
Cleared 510(K)
K
19
0274
Endotracheal Tube
2
Cleared 510(K)
K
18
1880
VivaSight-SL (TVT) system
2
Cleared 510(K)
K
17
1917
Frova Intubating Introducer
2
Cleared 510(K)
K
17
2208
NeVap Aspire Subglottic Suction Endotracheal Tube (ASSET) with Preloaded Stylet
2
Cleared 510(K)
K
17
0234
Endotracheal tube; Reinforced Endotracheal tube
2
Cleared 510(K)
K
17
1411
IRRIS (Infra-Red-Red Intubation System)
2
Cleared 510(K)
K
16
1813
Frova Intubating Introducer
2
Cleared 510(K)
K
16
0694
Disposable Endotracheal tube, sterile, AccuCuff
2
Cleared 510(K)
K
15
2438
ETView VivaSight-SL (TVT) system
2
Cleared 510(K)
K
15
1381
Mallinckrodt Oral/Nasal Tracheal Tube Cuffless, Non-DEHP, Murphy Eye
2
Cleared 510(K)
K
15
0603
Rusch Safety Silk Pediatric Series Oral/Nasal Tracheal Tube
2
Cleared 510(K)
K
14
1747
RHINOGUARD
2
Cleared 510(K)
K
14
0228
DISPOSABLE TRACHEAL TUBE
2
Cleared 510(K)
K
14
1939
TELEFELX ISIS HVT TRACHEAL TUBE, CUFFED WITH SUBGLOTTIC SECRETION SUCTION PORT; WITH STYLET
2
Cleared 510(K)
K
13
2415
RUSCH SAFETY SILK SERIES ORAL/NASAL TRACHEAL TUBE
2
Cleared 510(K)
K
13
1254
KIMVENT MICROCUFF SUBGLOTTIC SUCTIONING ENDOTRACHEAL TUBE
2
Cleared 510(K)
K
12
0985
KIMVENT MICROCUFF SUBGLOTTIC SUCTIONING
2
Cleared 510(K)
K
11
1401
BEVER ENDOTRACHEAL TUBE, BEVER EVA ENDOTRACHEAL TUBE
2
Cleared 510(K)
K
11
1406
BEVER REINFORCED ENDOTRACHEAL TUBE WITH CUFF (ORAL/NASAL), BEVER REINFORCED ENDOTRACHEAL TUBE WITHOUT CUFF (ORAL/NASAL)
2
Cleared 510(K)
K
12
1028
ETVIEW TRACHEOSCOPIC VENTILATION TUBE (TVT(TM))
2
Cleared 510(K)
K
11
3333
KIMBERLY-CLARK KIM VENT MICROCUFF ENDOTRACHEAL TUBE FOR ADULTS
2
Cleared 510(K)
K
11
0962
AMBU ASCOPE 2
2
Cleared 510(K)
K
11
0269
WELL LEAD ENDOTRACHEAL TUBE WITH EVACUATION LUMEN-ORAL
2
Cleared 510(K)
K
10
0546
PARKER FLEX- TIP ORAL/NASA INTUBATION TUBE
2
Cleared 510(K)
K
09
3186
AMBU ASCOPE AND MONITOR
2
Cleared 510(K)
K
09
3135
VENNER PNEUX P.Y. (TM) TRACHEOSTOMY TUBE AND ENDO TRACHEAL TUBE
2
Cleared 510(K)
K
09
1761
TELEFLEX ISIS HVT TRACHEAL TUBE, CUFFED, WITH SUBGLOTTIC SECRETION SUCTION PORT
2
Cleared 510(K)
K
09
0777
EZC MEDICAL, LLC INTUBAIDFLEX
2
Cleared 510(K)
K
08
3119
PORTEX TRACHEAL TUBE, SIZES 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 9.5
2
Cleared 510(K)
K
09
1591
FLEXICARE MEDICAL ENDOTRACHEAL TUBES
2
Cleared 510(K)
K
08
2038
CLARUS VIDEO AIRWAY ENDOSCOPE, MODELS 30000-V AND 30003-V
2
Cleared 510(K)
K
09
0352
TAPERGUARD ENDOTRACHEAL TUBES, TAPERGUARD EVAC ENDOTRACHEAL TUBES
2
Cleared 510(K)
K
08
0105
ENDOTRACHEAL TUBE
2
Cleared 510(K)
K
08
0339
MEDSOURCE ENDOTRACHEAL TUBE (WITH AND WITHOUT CUFF)
2
Cleared 510(K)
K
08
2420
TRACHEOSCOPIC VENTILATION TUBE (TVT)
2
Cleared 510(K)
K
08
2520
SEALGUARD EVAC ENDOTRACHEAL AND ENDOTRACHEAL TUBES
2
Cleared 510(K)
K
08
1086
PORTEX BLUE LINE SACETT SUCTION ABOVE THE CUFF TRACHEAL TUBE, SIZE 6.0 AND 6.5, 7.0 AND 7.5, 8.0 AND 8.5, 9.0
2
Cleared 510(K)
K
07
3383
WELL LEAD REINFORCED ENDOTRACHEAL TUBE
2
Cleared 510(K)
K
08
0821
MICROCUFF PEDIATRIC ENDOTRACHEAL TUBE
2
Cleared 510(K)
K
08
0170
AGENTO I.C. SILVER-COATED ENDOTRACHEAL TUBE (IHVLP)
2
Cleared 510(K)
K
07
1365
AGENTO I.C. SILVER-COATED ENDOTRACHEAL TUBE
2
Cleared 510(K)
K
06
0094
ARCADIA MEDICAL SILICONE WIRE REINFORCED ENDOTRACHEAL TUBES
2
Cleared 510(K)
K
05
2233
TRACHEOSCOPIC VENTILATION TUBE (TVT) SYSTEM
2
Cleared 510(K)
K
05
1993
LMA FASTRACH ETT SINGLE USE
2
Cleared 510(K)
K
05
0785
AMSINO ENDOTRACHEAL TUBE
2
Cleared 510(K)
K
05
0803
PEDIATRIC CUFFED AND UNCUFFED ET TUBES; STANDARD CUFFED AND UNCUFFED ET TUBES
2
Cleared 510(K)
K
04
1311
TIGER ENDOTRACHEAL TUBES (VARIOUS MODELS AND SIZES)
2
Cleared 510(K)
K
04
2683
WELL LEAD ENDOTRACHEAL TUBE
2
Cleared 510(K)
K
04
3205
RUSCH EASY TUBE
2
Cleared 510(K)
K
04
1917
PLASIATEK ACTUATOR
2
Cleared 510(K)
K
04
0657
BOUSSIGNAC/VYGON ENDOTRACHEAL TUBE, MODEL 6501.25/30/35 AND 6502.70/75/80
2
Cleared 510(K)
K
03
1794
ENDOFLEX TRACHEAL TUBE
2
Cleared 510(K)
K
03
2112
P0RTEX REINFORCED TRACHEAL TUBE (CUFFED AND UNCUFFED)
2
Cleared 510(K)
K
03
0792
BARD ENDOTRACHEAL TUBE, CUFFED
2
Cleared 510(K)
K
02
3964
RUSCH MICROLARYNGEAL TUBE
2
Cleared 510(K)
K
02
1044
MADETT
2
Cleared 510(K)
K
02
1540
RUSCH EDGAR TUBE
2
Cleared 510(K)
K
01
3321
SILICONE TRACHEAL T-TUBES
2
Cleared 510(K)
K
00
0045
POSITUBE
2
Cleared 510(K)
K
99
1580
ILM ENDOTRACHEAL TUBE
2
Cleared 510(K)
K
99
3786
RUSCH ORAL/NASAL (SAFETY CLEAR PLUS) TRACHEAL TUBE CUFFED, MAGILL/MURPHY
2
Cleared 510(K)
K
99
3582
MODIFICATION TO LASER-SHIELD II
2
Cleared 510(K)
K
99
0619
RUSCH REINFORCED ENDOTRACHEAL (OR TRACHEAL) TUBE- CUFFED AND UNCUFFED MURPHY/MAGILL, STERILE
2
Cleared 510(K)
K
98
4528
PARKER FLEX-TIP TRACHEAL TUBE
2
Cleared 510(K)
K
99
0556
ESOPHAGEAL INTUBATION DETECTOR
2
Cleared 510(K)
K
99
0098
VENTLAB VERIFY II
2
Cleared 510(K)
K
98
1891
AMBU TUBECHECK
2
Cleared 510(K)
K
97
1759
MEDPORT EMERGENCY MEDICATION AIRWAY TUBE ADAPTER
2
Cleared 510(K)
K
97
3191
THE VISUALIZED ENDOTRACHEAL TUBE SYSTEM OR VETT SYSTEM
2
Cleared 510(K)
K
97
0196
T-WALL UNCUFFED TRACHEAL TUBE
2
Cleared 510(K)
K
96
5132
HI-LO EVAC AND EVAC II ENDOTRACHEAL TUBES
2
Cleared 510(K)
K
96
2389
EUROMEDICAL REINFORCED ENDOTRACHEAL TUBE
2
Cleared 510(K)
K
96
2098
ESOPHAGEAL INTUBATION DETECTOR
2
Cleared 510(K)
K
96
1837
RUSH ORAL/NASAL TRACHEAL TUBE CUFFED MAGILL/MURPHY
2
Cleared 510(K)
K
96
1840
RUSCH ORAL/NASAL TRACHEAL TUBE, PLAIN MAGILL/MURPHY
2
Cleared 510(K)
K
95
5495
RUSCH REINFORCED TRACHAEL TUBE CUFFED, STERILE
2
Cleared 510(K)
K
96
0795
VYGON DOUBLE LUMEN ENDOTRACHEAL TUBE
2
Cleared 510(K)
K
95
4585
RUSCH PEDIATRIC REINFORCED TRAHEAL (OR ENDOTRACHEAL) TUBE - UNCUFFED, STERILE
2
Cleared 510(K)
K
96
0450
HEBELER SAFE-T-TUBE
2
Cleared 510(K)
K
95
1768
TEVES ECM PLUS THERMOCOUPLE
2
Cleared 510(K)
K
95
4754
WIRE REINFORCED SILICONE ENDOTRACHEAL TUBE
2
Cleared 510(K)
K
95
4753
PEDIATRIC SILICONE ENDOTRACHEAL TUBE
2
Cleared 510(K)
K
95
4751
SILICONE ENDOTRACHEAL TUBE
2
Cleared 510(K)
K
95
4750
PEDIATRIC WIRE REINFORCED SILICONE ENDOTRACHEAL TUBE
2
Cleared 510(K)
K
95
3368
LUER, JACKSON TRACHEA TUBES, LUER SPEAKING TRACHEA TUBES
2
Cleared 510(K)
K
93
5842
RUSCH LASERTUBUS/RUSCH LASER RESISTANT CUFFED WITH MURPHY EYE
2
Cleared 510(K)
K
95
2013
PRIMA GUEDEL AIRWAYS
2
Cleared 510(K)
K
95
1697
PEDIATRIC ENDOTRACHEAL TUBE
2
Cleared 510(K)
K
95
1696
ENDOTRACHEAL TUBE
2
Cleared 510(K)
K
92
4997
EDD
2
Cleared 510(K)
K
94
5816
QUICK-LOCK
2
Cleared 510(K)
K
94
5455
GENERAL ANESTHESIA SYSTEM
2
Cleared 510(K)
K
94
5745
ESOPHAGEAL INTUBATION DETECTOR ADAPTER - (EID-ADAPTER)
2
Cleared 510(K)
K
94
4324
SURE-LOCK VENTILATOR TUBING HOLDER
2
Cleared 510(K)
K
94
2628
ESOPHAGEAL INTUBATION DETECTOR BULB
2
Cleared 510(K)
K
94
0041
COLIBRI
2
Cleared 510(K)
K
94
1969
ENDOPLUS
2
Cleared 510(K)
K
94
1246
RAE II TRACHEAL TUBE
2
Cleared 510(K)
K
93
4465
DIC TRACHEOSTOMY TUBE AND PORTEX BLUE LINE
2
Cleared 510(K)
K
93
2647
WIRE REINFORCED ENDOTRACHEAL TUBE
2
Cleared 510(K)
K
93
4117
STABILTUBE
2
Cleared 510(K)
K
93
3398
BIVONA ILLUMINATED ENDOTRACHEAL TUBE
2
Cleared 510(K)
K
92
5508
RUSCH SAFETY CLEAR PLUS CUFFED W/MAGILL TIP
2
Cleared 510(K)
K
92
5505
RUSCH SAFETY CLEAR PLUS CUFFED W/MURPHY EYE
2
Cleared 510(K)
K
92
5507
RUSCH SAFETY CLEAR UNCUFFED WITH MAGILL TIP
2
Cleared 510(K)
K
93
1749
BIVONA(R) ICU ENDOTRACHEAL TUBE
2
Cleared 510(K)
K
93
0741
ESOPHAGEAL INTUBATION DETECTOR
2
Cleared 510(K)
K
92
5506
RUSCH SAFETY CLEAR UNCUFFED WITH MURPHY EYE
2
Cleared 510(K)
K
93
2711
PRECISION MED PRODUCTS LTD GUEDEL AIRWAYS
2
Cleared 510(K)
K
93
2561
GUEDEL AIRWAYS
2
Cleared 510(K)
K
93
2280
RAE(R) II TRACHEAL TUBE
2
Cleared 510(K)
K
93
1164
RUSCH AGT PVC PREFORM NASAL TRACH TUB/CUF W/MUR EY
2
Cleared 510(K)
K
93
1163
RUSCH AGT PVC PREFORM ORAL TRACH TUB/CUF W/MUR EYE
2
Cleared 510(K)
K
93
1166
RUSCH AGT PVC PREF ORAL TRACH TUBE, UNCUF W/MUR EY
2
Cleared 510(K)
K
93
1165
RUSCH AGT PVC PREF NASAL TRACH TUB/UNCUF W/MUR EYE
2
Cleared 510(K)
K
93
1735
BLUE LINE(R) PDT(TM) PORTEX DIRECTIONAL TUBE
2
Cleared 510(K)
K
92
2894
LAZER-TRACH TRACHEAL TUBE
2
Cleared 510(K)
K
92
5781
DISPOSABLE CUFFED ENDOTRACHEAL TUBE
2
Cleared 510(K)
K
92
2880
XOMED TREACE JET VENTILATION TUBE
2
Cleared 510(K)
K
92
6498
ENDOGRIP
2
Cleared 510(K)
K
93
0114
TRACHEOSTOMY T-TUBE
2
Cleared 510(K)
K
92
3591
PALA-NATE
2
Cleared 510(K)
K
93
0179
TRACHEAL TUBE FIXATION DEVICE
2
Cleared 510(K)
K
92
5855
DISPOSABLE UNCUFFED ENDOTRACHEAL TUBE
2
Cleared 510(K)
K
93
0150
SAFE-T-TUBE RADIOPAQUE
2
Cleared 510(K)
K
91
4370
MECONIUM SUCTION DEVICE (MSD)
2
Cleared 510(K)
K
92
1077
DISPOSABLE INTUBATION KITS
2
Cleared 510(K)
K
91
0463
MEROCEL(R) LASER-GUARD(TM)
2
Cleared 510(K)
K
91
5277
ENDOTRACHEAL CPAP SET
2
Cleared 510(K)
K
92
0900
POLAMEDCO TRACHEAL AND NASOTRACHEAL TUBES
2
Cleared 510(K)
K
91
5799
BIVONA SLEEP APNEA TUBE
2
Cleared 510(K)
K
91
2290
HEALY/MONTGOMERY STENT SYSTEM (HMS SYSTEM(TM))
2
Cleared 510(K)
K
90
2193
KEVTEK LASER-STOP ENDOTRACHEAL TUBE LASER-STOP
2
Cleared 510(K)
K
90
3876
MONTGOMERY(R) TAPERED SAFE-T-TUBE(TM)
2
Cleared 510(K)
K
90
0457
CUFFED LINDER NASOTRACHEAL AIRWAY
2
Cleared 510(K)
K
89
6181
APT TRACHEA TUBES
2
Cleared 510(K)
K
89
3609
TEVES ECM (ENDOTRACHEAL CARDIAC MONITOR)
2
Cleared 510(K)
K
89
5132
CONNELL-STEPHENS ENDO ANESS TUBE
2
Cleared 510(K)
K
89
4669
LASER SHIELDING TUBE
2
Cleared 510(K)
K
89
2432
KENDALL CURITY ENDOTRACHEAL TUBES
2
Cleared 510(K)
K
88
3096
TRACHEAL TUBE LASER SHIELD KIT
2
Cleared 510(K)
K
88
1496
LINDER NASOTRACHEAL AIRWAY
2
Cleared 510(K)
K
88
1313
IQK-200
2
Cleared 510(K)
K
88
0487
NEOTECH MECONIUM ASPIRATOR (STERILE)
2
Cleared 510(K)
K
88
0960
NDYAG LASER TRACHEAL TUBE
2
Cleared 510(K)
K
87
4679
TRACHEAL TUBE LASER SHIELD KIT
2
Cleared 510(K)
K
87
3461
LASER-FLEX(TM) TRACHEAL TUBE (CUFFED)
2
Cleared 510(K)
K
87
1632
NASOGASTRIC VOICETUBE
2
Cleared 510(K)
K
87
2366
AIRE-CUF POLYESTER RE-ENFORCED ENDOTRACHEAL TUBE
2
Cleared 510(K)
K
87
2616
BELL/MCKAY TRACHEAL TUBE
2
Cleared 510(K)
K
87
1263
MULTIPLE PHARMA-PLAST TRACHEAL TUBE
2
Cleared 510(K)
K
87
0470
TRACH MATE TRACHEAL TUBE
2
Cleared 510(K)
K
87
0387
EUROMEDICAL, ENDOSOFT ENDOTRACHEAL TUBE
2
Cleared 510(K)
K
87
1204
CUFFED TRACHEAL TUBE (MULTIPLE)
2
Cleared 510(K)
K
86
4533
HOOD BIFURCATED T-TUBE
2
Cleared 510(K)
K
86
4161
TOOB-CHEQ CARBON DIOXIDE GAS ANALYZER
2
Cleared 510(K)
K
86
2950
WHITE-SIPOSS TUBE, CAT NO WS-1
2
Cleared 510(K)
K
86
2238
BIVONA FOME-CUF LASER ENDOTRACHEAL TUBE
2
Cleared 510(K)
K
86
2666
UNCUFFED LASER RESISTEANT TRACHEAL TUBE(TENTATIVE)
2
Cleared 510(K)
K
86
2347
ENDOTRACHEAL TUBE, ACCESSORY
2
Cleared 510(K)
K
86
0901
LASER RESISTANT TRACHEAL TUBE (TENTATIVE)
2
Cleared 510(K)
K
86
1461
SHILEY SLEEP APNEA CUFFLESS FENESTRATED TRACH TUBE
2
Cleared 510(K)
K
86
1463
SHILEY SLEEP APNEA LOW PRESSURE CUFFED TRACH TUBE
2
Cleared 510(K)
K
86
1462
SHILEY SLEEP APNEA CUFFLESS TRACHEOSTOMY TUBE
2
Cleared 510(K)
K
86
1454
END TIDAL CO2 TUBE
2
Cleared 510(K)
K
86
0105
SPIRAL-FLEX
2
Cleared 510(K)
K
85
4632
ENDOTRACHEAL TUBE GUIDE OR INTUBATION STYLETTE
2
Cleared 510(K)
K
85
3502
VARIOUS FOME-CUF TRACHEAL TUBES W/SIDEPORT AIRWAY
2
Cleared 510(K)
K
85
2025
BRANDT TRACHEAL TUBE(TENTATIVE)
2
Cleared 510(K)
K
85
2493
UNCUFFED HI-LO JET TRACHEAL TUBE
2
Cleared 510(K)
K
84
4696
TROGIDE
2
Cleared 510(K)
K
84
3988
S.E.T. TUBE
2
Cleared 510(K)
K
84
4564
ARGYLE LASER RESISTANT TRACHEAL TUBE W/MURPHY EYE
2
Cleared 510(K)
K
84
4746
TRACHEAL TUBE W/AIRWAY INTUBATOR
2
Cleared 510(K)
K
84
3936
MONTGOMERY SAFE-T-TUBE
2
Cleared 510(K)
K
84
4296
TRACHEAL TUBE, REINFORCED, CUFFED
2
Cleared 510(K)
K
84
3714
DOUBLE CONTOURED CUFF TRACHEAL TUBE
2
Cleared 510(K)
K
84
1872
UNCUFFED REINFORCED TRACHEAL TUBE
2
Cleared 510(K)
K
84
2635
SHERIDAN/ENDO-PAK
2
Cleared 510(K)
K
84
2558
SHERIDAN/INTENSA TUBE
2
Cleared 510(K)
K
84
2464
TRACHEAL TUBE/STETHOSCOPE
2
Cleared 510(K)
K
84
0943
ENDO-JECT
2
Cleared 510(K)
K
84
0973
COLE TUBE-LATEX
2
Cleared 510(K)
K
83
3831
3-DAY BIOINDICATOR RELEASE FOR STERIL
2
Cleared 510(K)
K
83
3807
ARGYLE JET TRACHEAL TUBE
2
Cleared 510(K)
K
83
3197
TRACH SWIVE/CONNECTOR
2
Cleared 510(K)
K
83
2629
INTUBATION KIT
2
Cleared 510(K)
K
83
0631
TRACHEAL TUBE W/ILLUMINATING LOCATER
2
Cleared 510(K)
K
82
3757
SURGITEK ENDOTRACHEAL TUBE, LASER RESIS
2
Cleared 510(K)
K
83
0504
SURGITEK ULTRA-LO CUFF
2
Cleared 510(K)
K
83
0352
REINFORCED SILICONE TRACHEAL TUBE
2
Cleared 510(K)
K
82
2082
SHERIDAN/HVT,CF, UNCUFFED
2
Cleared 510(K)
K
82
1670
ARGYLE TARTAN I TRACHEAL TUBE
2
Cleared 510(K)
K
82
1456
ENDOTRACHEAL TUBE
2
Cleared 510(K)
K
82
1243
ENDOTRACHEAL TUBE
2
Cleared 510(K)
K
82
1180
TRACELON
2
Cleared 510(K)
K
82
1027
SOFT TIP LOW PRESSURE CUFFED ORAL/NASAL
2
Cleared 510(K)
K
81
3373
VYGON ENDOTRACHEAL TUBES
2
Cleared 510(K)
K
81
2880
OHIO NON-REUSABLE TRACHEAL TUBE MAJILL
2
Cleared 510(K)
K
81
2879
OHIO NON-REUSABLE TRACHEAL TUBE MURPHY
2
Cleared 510(K)
K
81
2943
SLICK ENDOTRACHEAL TUBE
2
Cleared 510(K)
K
81
1937
ARGYLE TARTAN TRACHEAL TUBE
2
Cleared 510(K)
K
81
1888
LINDHOLM ANATOMICAL TRACHEAL TUBE
2
Cleared 510(K)
K
81
0763
OHIO DISPOSABLE TRACHEAL TUBE
2
Cleared 510(K)
K
80
2505
DOUBLE LUMEN TRACHEAL TUBE
2
Cleared 510(K)
K
81
0151
SLICK SET W/SURELOC EXTERNAL CONNECTOR
2
Cleared 510(K)
K
80
1213
CONCEPT ENDOTRACHEAL TUBE
2
Cleared 510(K)
K
80
1005
MLT TUBE MICROLARYNGEAL TRACHEAL TUBE)
2
Cleared 510(K)
K
80
0634
OHIO DISPOSABLE TRACHEAL TUBE
2
Cleared 510(K)
K
79
2035
FOME-CUF-WIRE RE-ENFORCED, AIRE-CUF WIRE
2
Cleared 510(K)
K
79
1046
ENDOTRACHEAL TUBES, LONG & SHORT TERM
2
Cleared 510(K)
K
79
1045
MODEL GV-10 LANZ PRESSURE-VALVE
2
Cleared 510(K)
K
79
0927
OXYGENERATOR NO. M-049
2
Cleared 510(K)
K
79
0575
TUBE, ARMORED TRACHEAL
2
Cleared 510(K)
K
79
0312
ENDOTRACHEAL TUBE W/HOLDER & CONNECTOR
2
Cleared 510(K)
K
78
1713
ADAPTER, C/D SUCTION
2
Cleared 510(K)
K
78
1808
SLICK SET, CUFFED
2
Cleared 510(K)
K
78
1339
ENDOTRACHEAL TUBE
2
Cleared 510(K)
K
78
0900
SLICK SET
2
Cleared 510(K)
K
78
0583
FOME-CUF PVC
2
Cleared 510(K)
K
77
1197
NORTON ENDOTRACHEAL
2
Cleared 510(K)
K
76
0998
ENDOTRACHAEL TUBE AND HOLDER
2
Cleared 510(K)
BTS
Tube, Bronchial (W/Wo Connector)
2
Product Code
BTT
Humidifier, Respiratory Gas, (Direct Patient Interface)
2
Product Code
BWB
Forceps, Tube Introduction
1
Product Code
BWC
Needle, Emergency Airway
2
Product Code
BWF
Spirometer, Therapeutic (Incentive)
2
Product Code
BWL
Apparatus, Electronanesthesia
3
Product Code
BYD
Condenser, Heat And Moisture (Artificial Nose)
1
Product Code
BYE
Attachment, Breathing, Positive End Expiratory Pressure
2
Product Code
BYF
Mask, Oxygen, Low Concentration, Venturi
1
Product Code
BYG
Mask, Oxygen
1
Product Code
BYH
Drain, Tee (Water Trap)
1
Product Code
BYI
Percussor, Powered-Electric
2
Product Code
BYJ
Unit, Liquid-Oxygen, Portable
2
Product Code
BYK
Tent, Oxygen, Electrically Powered
2
Product Code
BYL
Tent, Oxygen
1
Product Code
BYN
Chair, Posture, For Cardiac And Pulmonary Treatment
1
Product Code
BYO
Bottle, Blow
1
Product Code
BYP
Mouthpiece, Breathing
1
Product Code
BYT
Ventilator, External Body, Negative Pressure, Adult (Cuirass)
2
Product Code
BYW
Device, Rebreathing
1
Product Code
BYX
Tubing, Pressure And Accessories
1
Product Code
BZA
Connector, Airway (Extension)
1
Product Code
BZB
Catheter, Nasal, Oxygen
1
Product Code
BZD
Ventilator, Non-Continuous (Respirator)
2
Product Code
BZE
Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer
2
Product Code
BZO
Set, Tubing And Support, Ventilator (W Harness)
1
Product Code
BZR
Mixer, Breathing Gases, Anesthesia Inhalation
2
Product Code
CAD
Vaporizer, Anesthesia, Non-Heated
2
Product Code
CAE
Airway, Oropharyngeal, Anesthesiology
1
Product Code
CAF
Nebulizer (Direct Patient Interface)
2
Product Code
CAG
Circulator, Breathing-Circuit
2
Product Code
CAI
Circuit, Breathing (W Connector, Adaptor, Y Piece)
1
Product Code
CAL
Laryngoscope, Non-Rigid
1
Product Code
CAO
Airway, Esophageal (Obturator)
2
Product Code
CAT
Cannula, Nasal, Oxygen
1
Product Code
CAW
Generator, Oxygen, Portable
2
Product Code
CAZ
Anesthesia Conduction Kit
2
Product Code
CBF
Chamber, Hyperbaric
2
Product Code
CBG
Spreader, Cuff
1
Product Code
CBH
Device, Fixation, Tracheal Tube
1
Product Code
CBI
Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)
2
Product Code
CBK
Ventilator, Continuous, Facility Use
2
Product Code
CBL
Absorbent, Carbon-Dioxide
1
Product Code
CBN
Apparatus, Gas-Scavenging
2
Product Code
CBO
Attachment, Intermittent Mandatory Ventilation (Imv)
2
Product Code
CBP
Valve, Non-Rebreathing
2
Product Code
MOD
Accessory To Continuous Ventilator (Respirator)
2
Product Code
CCO
Bed, Rocking, Breathing Assist
2
Product Code
CCQ
Nebulizer, Medicinal, Non-Ventilatory (Atomizer)
1
Product Code
CCT
Applicator (Laryngo-Tracheal), Topical Anesthesia
2
Product Code
CCW
Laryngoscope, Rigid
1
Product Code
EPE
Brush, Cleaning, Tracheal Tube
1
Product Code
FNC
Tent, Pediatric Aerosol
2
Product Code
FOG
Hood, Oxygen, Infant
1
Product Code
JAY
Support, Breathing Tube
1
Product Code
JOH
Tube Tracheostomy And Tube Cuff
2
Product Code
KFZ
Humidifier, Non-Direct Patient Interface (Home-Use)
1
Product Code
KGB
Mask, Oxygen, Non-Rebreathing
1
Product Code
KHA
Mask, Scavenging
1
Product Code
LNZ
Changer, Tube, Endotracheal
2
Product Code
MIA
Needle, Spinal, Short Term
2
Product Code
MNS
Ventilator, Continuous, Non-Life-Supporting
2
Product Code
MNT
Ventilator, Continuous, Minimal Ventilatory Support, Facility Use
2
Product Code
MRN
Apparatus, Nitric Oxide Delivery
2
Product Code
MRO
Apparatus, Nitric Oxide, Backup Delivery
2
Product Code
MZT
Device, Heimlich Maneuver Assist
2
Product Code
NFB
Conserver, Oxygen
2
Product Code
NHJ
Device, Positive Pressure Breathing, Intermittent
2
Product Code
NHK
Resuscitator, Manual, Non Self-Inflating
2
Product Code
NMA
Tube, Tracheal, Reprocessed
2
Product Code
NMC
Mask, Ventilator, Non-Continuous, Reprocessed
2
Product Code
NMR
Needle, Spinal, Short Term, Reprocessed
2
Product Code
NNH
Needle, Conduction, Anesthesia, Reprocessed
2
Product Code
NOU
Continuous, Ventilator, Home Use
2
Product Code
NQY
Ventilator, Continuous, Minimal Ventilatory Support, Home Use
2
Product Code
NVO
Spacer, Direct Patient Interface
2
Product Code
NVP
Holding Chambers, Direct Patient Interface
2
Product Code
NXA
Tracheotomy Care Kit
2
Product Code
OBN
Humidifier, Respiratory, Mask (Direct Patient Interface)
2
Product Code
OFQ
Anesthesia Kit
2
Product Code
OFT
Spinal Epidural Anesthesia Kit
2
Product Code
OFU
Spinal Anesthesia Kit
2
Product Code
OFV
Regional Anesthesia Kit
2
Product Code
OGA
Brachial Plexus Anesthesia Kit
2
Product Code
OGB
Caudal Anesthesia Kit
2
Product Code
OGC
Continuous Brachial Plexus Block Tray
2
Product Code
OGD
Custom Anesthesia Tray
2
Product Code
OGE
Epidural Anesthesia Kit
2
Product Code
OGF
Glossopharyngeal Anesthesia Kit
2
Product Code
OGG
Humidifier Nebulizer Kit
2
Product Code
OGH
Laryngoscope Kit
1
Product Code
OGI
Nasal Endotracheal Tube Holder Kit
1
Product Code
OGJ
Nerve Block Tray
2
Product Code
OGL
Oxygen Administration Kit
2
Product Code
OLF
Medevac Use Oxygen Generator
2
Product Code
ONZ
Mechanical Ventilator
2
Product Code
OQU
Airway Monitoring System
2
Product Code
PHS
Oral Airway Assist
1
Product Code
PMB
External Airway
2
Product Code
QAV
High Flow/High Velocity Humidified Oxygen Delivery Device
2
Product Code
QBY
Positive Airway Pressure System
2
Product Code
QCX
Retrograde Intubation Set
2
Product Code
OZR
Intraoral Pressure Gradient Device
2
Product Code
QFB
Isocapnic Ventilation Device
2
Product Code
Subpart G—Miscellaneous
CFR Sub-Part
Cardiovascular
Review Panel
Chemistry
Review Panel
Dental
Review Panel
Ear, Nose, Throat
Review Panel
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 30 November 2024 at 11:09 am
AN
/
subpart-f—therapeutic-devices
/
BTR
/
K170234
View Source
Endotracheal tube; Reinforced Endotracheal tube
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K170234
510(k) Type
Traditional
Applicant
Zhanjiang Star Enterprise Co., Ltd
Country
Taiwan
FDA Decision
Substantially Equivalent
Decision Date
1/17/2018
Days to Decision
357 days
Submission Type
Summary
FDA Browser
by
Innolitics
Anesthesiology
Miscellaneous
Subpart B—Cardiovascular Diagnostic Devices
Subpart B—Diagnostic Devices
Subpart C—Cardiovascular Monitoring Devices
Subpart C—Monitoring Devices
Subpart D—Prosthetic Devices
Subpart E—Surgical Devices
Subpart F—Cardiovascular Therapeutic Devices
Subpart F—Neurological Therapeutic Devices
Subpart F—Physical Medicine Therapeutic Devices
Subpart F—Therapeutic Devices
BRW
Protector, Dental
BSF
Absorber, Carbon-Dioxide
BSJ
Mask, Gas, Anesthetic
BSK
Cuff, Tracheal Tube, Inflatable
BSN
Filter, Conduction, Anesthetic
BSO
Catheter, Conduction, Anesthetic
BSP
Needle, Conduction, Anesthetic (W/Wo Introducer)
BSR
Stylet, Tracheal Tube
BSZ
Gas-Machine, Anesthesia
BTB
Hook, Ether
BTC
Bag, Reservoir
BTK
Strap, Head, Gas Mask
BTL
Ventilator, Emergency, Powered (Resuscitator)
BTM
Ventilator, Emergency, Manual (Resuscitator)
BTO
Tube, Tracheostomy (W/Wo Connector)
BTP
Dropper, Ether
BTQ
Airway, Nasopharyngeal
BTR
Tube, Tracheal (W/Wo Connector)
K
23
3341
Shiley™ Oral/Nasal Endotracheal Tube Intermediate Cuff, Non-DEHP (87430, 87435, 87440, 87445, 87450, 87455, 87460, 87465, 87470, 87475, 87480, 87485, 87490, 87495, 87410)
K
22
3130
Shiley™ Pediatric Oral/Nasal Endotracheal Tube with TaperGuard™ Cuff, Non DEHP (86125, 86130, 86135, 86140, 86145, 86150, 86155, 86160)
K
21
1543
Wei Nasal Jet Tube
K
21
3028
Tenax Laser Resistant Endotracheal Tube
K
20
0761
Tenax Laser Resistant Endotracheal Tube
K
19
2120
Venner PneuX™ ETT (Endotracheal Tube) 6 mm, Venner PneuX™ ETT (Endotracheal Tube) 7 mm, Venner PneuX™ ETT (Endotracheal Tube) 8 mm, Venner PneuX™ ETT (Endotracheal Tube) 9 mm
K
19
0878
Trach- Vac Endotracheal Tube (SFTVPU) Subglottic Suction Tube with Salter Flex-Tip and Salter ThinCuff, Trach- Vac Endotracheal Tube (SFTVVC) Subglottic Suction Tube with Salter Flex-Tip and Salter ThinCuff
K
18
2739
Endotracheal Tube with Evacuation Lumen
K
19
2324
Sheridan Spiral-Flex Endotracheal Tubes
K
19
0630
SolidAIRity III Airway Stabilization System
K
19
0213
Yikang Endotracheal Tube
K
19
0274
Endotracheal Tube
K
18
1880
VivaSight-SL (TVT) system
K
17
1917
Frova Intubating Introducer
K
17
2208
NeVap Aspire Subglottic Suction Endotracheal Tube (ASSET) with Preloaded Stylet
K
17
0234
Endotracheal tube; Reinforced Endotracheal tube
K
17
1411
IRRIS (Infra-Red-Red Intubation System)
K
16
1813
Frova Intubating Introducer
K
16
0694
Disposable Endotracheal tube, sterile, AccuCuff
K
15
2438
ETView VivaSight-SL (TVT) system
K
15
1381
Mallinckrodt Oral/Nasal Tracheal Tube Cuffless, Non-DEHP, Murphy Eye
K
15
0603
Rusch Safety Silk Pediatric Series Oral/Nasal Tracheal Tube
K
14
1747
RHINOGUARD
K
14
0228
DISPOSABLE TRACHEAL TUBE
K
14
1939
TELEFELX ISIS HVT TRACHEAL TUBE, CUFFED WITH SUBGLOTTIC SECRETION SUCTION PORT; WITH STYLET
K
13
2415
RUSCH SAFETY SILK SERIES ORAL/NASAL TRACHEAL TUBE
K
13
1254
KIMVENT MICROCUFF SUBGLOTTIC SUCTIONING ENDOTRACHEAL TUBE
K
12
0985
KIMVENT MICROCUFF SUBGLOTTIC SUCTIONING
K
11
1401
BEVER ENDOTRACHEAL TUBE, BEVER EVA ENDOTRACHEAL TUBE
K
11
1406
BEVER REINFORCED ENDOTRACHEAL TUBE WITH CUFF (ORAL/NASAL), BEVER REINFORCED ENDOTRACHEAL TUBE WITHOUT CUFF (ORAL/NASAL)
K
12
1028
ETVIEW TRACHEOSCOPIC VENTILATION TUBE (TVT(TM))
K
11
3333
KIMBERLY-CLARK KIM VENT MICROCUFF ENDOTRACHEAL TUBE FOR ADULTS
K
11
0962
AMBU ASCOPE 2
K
11
0269
WELL LEAD ENDOTRACHEAL TUBE WITH EVACUATION LUMEN-ORAL
K
10
0546
PARKER FLEX- TIP ORAL/NASA INTUBATION TUBE
K
09
3186
AMBU ASCOPE AND MONITOR
K
09
3135
VENNER PNEUX P.Y. (TM) TRACHEOSTOMY TUBE AND ENDO TRACHEAL TUBE
K
09
1761
TELEFLEX ISIS HVT TRACHEAL TUBE, CUFFED, WITH SUBGLOTTIC SECRETION SUCTION PORT
K
09
0777
EZC MEDICAL, LLC INTUBAIDFLEX
K
08
3119
PORTEX TRACHEAL TUBE, SIZES 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 9.5
K
09
1591
FLEXICARE MEDICAL ENDOTRACHEAL TUBES
K
08
2038
CLARUS VIDEO AIRWAY ENDOSCOPE, MODELS 30000-V AND 30003-V
K
09
0352
TAPERGUARD ENDOTRACHEAL TUBES, TAPERGUARD EVAC ENDOTRACHEAL TUBES
K
08
0105
ENDOTRACHEAL TUBE
K
08
0339
MEDSOURCE ENDOTRACHEAL TUBE (WITH AND WITHOUT CUFF)
K
08
2420
TRACHEOSCOPIC VENTILATION TUBE (TVT)
K
08
2520
SEALGUARD EVAC ENDOTRACHEAL AND ENDOTRACHEAL TUBES
K
08
1086
PORTEX BLUE LINE SACETT SUCTION ABOVE THE CUFF TRACHEAL TUBE, SIZE 6.0 AND 6.5, 7.0 AND 7.5, 8.0 AND 8.5, 9.0
K
07
3383
WELL LEAD REINFORCED ENDOTRACHEAL TUBE
K
08
0821
MICROCUFF PEDIATRIC ENDOTRACHEAL TUBE
K
08
0170
AGENTO I.C. SILVER-COATED ENDOTRACHEAL TUBE (IHVLP)
K
07
1365
AGENTO I.C. SILVER-COATED ENDOTRACHEAL TUBE
K
06
0094
ARCADIA MEDICAL SILICONE WIRE REINFORCED ENDOTRACHEAL TUBES
K
05
2233
TRACHEOSCOPIC VENTILATION TUBE (TVT) SYSTEM
K
05
1993
LMA FASTRACH ETT SINGLE USE
K
05
0785
AMSINO ENDOTRACHEAL TUBE
K
05
0803
PEDIATRIC CUFFED AND UNCUFFED ET TUBES; STANDARD CUFFED AND UNCUFFED ET TUBES
K
04
1311
TIGER ENDOTRACHEAL TUBES (VARIOUS MODELS AND SIZES)
K
04
2683
WELL LEAD ENDOTRACHEAL TUBE
K
04
3205
RUSCH EASY TUBE
K
04
1917
PLASIATEK ACTUATOR
K
04
0657
BOUSSIGNAC/VYGON ENDOTRACHEAL TUBE, MODEL 6501.25/30/35 AND 6502.70/75/80
K
03
1794
ENDOFLEX TRACHEAL TUBE
K
03
2112
P0RTEX REINFORCED TRACHEAL TUBE (CUFFED AND UNCUFFED)
K
03
0792
BARD ENDOTRACHEAL TUBE, CUFFED
K
02
3964
RUSCH MICROLARYNGEAL TUBE
K
02
1044
MADETT
K
02
1540
RUSCH EDGAR TUBE
K
01
3321
SILICONE TRACHEAL T-TUBES
K
00
0045
POSITUBE
K
99
1580
ILM ENDOTRACHEAL TUBE
K
99
3786
RUSCH ORAL/NASAL (SAFETY CLEAR PLUS) TRACHEAL TUBE CUFFED, MAGILL/MURPHY
K
99
3582
MODIFICATION TO LASER-SHIELD II
K
99
0619
RUSCH REINFORCED ENDOTRACHEAL (OR TRACHEAL) TUBE- CUFFED AND UNCUFFED MURPHY/MAGILL, STERILE
K
98
4528
PARKER FLEX-TIP TRACHEAL TUBE
K
99
0556
ESOPHAGEAL INTUBATION DETECTOR
K
99
0098
VENTLAB VERIFY II
K
98
1891
AMBU TUBECHECK
K
97
1759
MEDPORT EMERGENCY MEDICATION AIRWAY TUBE ADAPTER
K
97
3191
THE VISUALIZED ENDOTRACHEAL TUBE SYSTEM OR VETT SYSTEM
K
97
0196
T-WALL UNCUFFED TRACHEAL TUBE
K
96
5132
HI-LO EVAC AND EVAC II ENDOTRACHEAL TUBES
K
96
2389
EUROMEDICAL REINFORCED ENDOTRACHEAL TUBE
K
96
2098
ESOPHAGEAL INTUBATION DETECTOR
K
96
1837
RUSH ORAL/NASAL TRACHEAL TUBE CUFFED MAGILL/MURPHY
K
96
1840
RUSCH ORAL/NASAL TRACHEAL TUBE, PLAIN MAGILL/MURPHY
K
95
5495
RUSCH REINFORCED TRACHAEL TUBE CUFFED, STERILE
K
96
0795
VYGON DOUBLE LUMEN ENDOTRACHEAL TUBE
K
95
4585
RUSCH PEDIATRIC REINFORCED TRAHEAL (OR ENDOTRACHEAL) TUBE - UNCUFFED, STERILE
K
96
0450
HEBELER SAFE-T-TUBE
K
95
1768
TEVES ECM PLUS THERMOCOUPLE
K
95
4754
WIRE REINFORCED SILICONE ENDOTRACHEAL TUBE
K
95
4753
PEDIATRIC SILICONE ENDOTRACHEAL TUBE
K
95
4751
SILICONE ENDOTRACHEAL TUBE
K
95
4750
PEDIATRIC WIRE REINFORCED SILICONE ENDOTRACHEAL TUBE
K
95
3368
LUER, JACKSON TRACHEA TUBES, LUER SPEAKING TRACHEA TUBES
K
93
5842
RUSCH LASERTUBUS/RUSCH LASER RESISTANT CUFFED WITH MURPHY EYE
K
95
2013
PRIMA GUEDEL AIRWAYS
K
95
1697
PEDIATRIC ENDOTRACHEAL TUBE
K
95
1696
ENDOTRACHEAL TUBE
K
92
4997
EDD
K
94
5816
QUICK-LOCK
K
94
5455
GENERAL ANESTHESIA SYSTEM
K
94
5745
ESOPHAGEAL INTUBATION DETECTOR ADAPTER - (EID-ADAPTER)
K
94
4324
SURE-LOCK VENTILATOR TUBING HOLDER
K
94
2628
ESOPHAGEAL INTUBATION DETECTOR BULB
K
94
0041
COLIBRI
K
94
1969
ENDOPLUS
K
94
1246
RAE II TRACHEAL TUBE
K
93
4465
DIC TRACHEOSTOMY TUBE AND PORTEX BLUE LINE
K
93
2647
WIRE REINFORCED ENDOTRACHEAL TUBE
K
93
4117
STABILTUBE
K
93
3398
BIVONA ILLUMINATED ENDOTRACHEAL TUBE
K
92
5508
RUSCH SAFETY CLEAR PLUS CUFFED W/MAGILL TIP
K
92
5505
RUSCH SAFETY CLEAR PLUS CUFFED W/MURPHY EYE
K
92
5507
RUSCH SAFETY CLEAR UNCUFFED WITH MAGILL TIP
K
93
1749
BIVONA(R) ICU ENDOTRACHEAL TUBE
K
93
0741
ESOPHAGEAL INTUBATION DETECTOR
K
92
5506
RUSCH SAFETY CLEAR UNCUFFED WITH MURPHY EYE
K
93
2711
PRECISION MED PRODUCTS LTD GUEDEL AIRWAYS
K
93
2561
GUEDEL AIRWAYS
K
93
2280
RAE(R) II TRACHEAL TUBE
K
93
1164
RUSCH AGT PVC PREFORM NASAL TRACH TUB/CUF W/MUR EY
K
93
1163
RUSCH AGT PVC PREFORM ORAL TRACH TUB/CUF W/MUR EYE
K
93
1166
RUSCH AGT PVC PREF ORAL TRACH TUBE, UNCUF W/MUR EY
K
93
1165
RUSCH AGT PVC PREF NASAL TRACH TUB/UNCUF W/MUR EYE
K
93
1735
BLUE LINE(R) PDT(TM) PORTEX DIRECTIONAL TUBE
K
92
2894
LAZER-TRACH TRACHEAL TUBE
K
92
5781
DISPOSABLE CUFFED ENDOTRACHEAL TUBE
K
92
2880
XOMED TREACE JET VENTILATION TUBE
K
92
6498
ENDOGRIP
K
93
0114
TRACHEOSTOMY T-TUBE
K
92
3591
PALA-NATE
K
93
0179
TRACHEAL TUBE FIXATION DEVICE
K
92
5855
DISPOSABLE UNCUFFED ENDOTRACHEAL TUBE
K
93
0150
SAFE-T-TUBE RADIOPAQUE
K
91
4370
MECONIUM SUCTION DEVICE (MSD)
K
92
1077
DISPOSABLE INTUBATION KITS
K
91
0463
MEROCEL(R) LASER-GUARD(TM)
K
91
5277
ENDOTRACHEAL CPAP SET
K
92
0900
POLAMEDCO TRACHEAL AND NASOTRACHEAL TUBES
K
91
5799
BIVONA SLEEP APNEA TUBE
K
91
2290
HEALY/MONTGOMERY STENT SYSTEM (HMS SYSTEM(TM))
K
90
2193
KEVTEK LASER-STOP ENDOTRACHEAL TUBE LASER-STOP
K
90
3876
MONTGOMERY(R) TAPERED SAFE-T-TUBE(TM)
K
90
0457
CUFFED LINDER NASOTRACHEAL AIRWAY
K
89
6181
APT TRACHEA TUBES
K
89
3609
TEVES ECM (ENDOTRACHEAL CARDIAC MONITOR)
K
89
5132
CONNELL-STEPHENS ENDO ANESS TUBE
K
89
4669
LASER SHIELDING TUBE
K
89
2432
KENDALL CURITY ENDOTRACHEAL TUBES
K
88
3096
TRACHEAL TUBE LASER SHIELD KIT
K
88
1496
LINDER NASOTRACHEAL AIRWAY
K
88
1313
IQK-200
K
88
0487
NEOTECH MECONIUM ASPIRATOR (STERILE)
K
88
0960
NDYAG LASER TRACHEAL TUBE
K
87
4679
TRACHEAL TUBE LASER SHIELD KIT
K
87
3461
LASER-FLEX(TM) TRACHEAL TUBE (CUFFED)
K
87
1632
NASOGASTRIC VOICETUBE
K
87
2366
AIRE-CUF POLYESTER RE-ENFORCED ENDOTRACHEAL TUBE
K
87
2616
BELL/MCKAY TRACHEAL TUBE
K
87
1263
MULTIPLE PHARMA-PLAST TRACHEAL TUBE
K
87
0470
TRACH MATE TRACHEAL TUBE
K
87
0387
EUROMEDICAL, ENDOSOFT ENDOTRACHEAL TUBE
K
87
1204
CUFFED TRACHEAL TUBE (MULTIPLE)
K
86
4533
HOOD BIFURCATED T-TUBE
K
86
4161
TOOB-CHEQ CARBON DIOXIDE GAS ANALYZER
K
86
2950
WHITE-SIPOSS TUBE, CAT NO WS-1
K
86
2238
BIVONA FOME-CUF LASER ENDOTRACHEAL TUBE
K
86
2666
UNCUFFED LASER RESISTEANT TRACHEAL TUBE(TENTATIVE)
K
86
2347
ENDOTRACHEAL TUBE, ACCESSORY
K
86
0901
LASER RESISTANT TRACHEAL TUBE (TENTATIVE)
K
86
1461
SHILEY SLEEP APNEA CUFFLESS FENESTRATED TRACH TUBE
K
86
1463
SHILEY SLEEP APNEA LOW PRESSURE CUFFED TRACH TUBE
K
86
1462
SHILEY SLEEP APNEA CUFFLESS TRACHEOSTOMY TUBE
K
86
1454
END TIDAL CO2 TUBE
K
86
0105
SPIRAL-FLEX
K
85
4632
ENDOTRACHEAL TUBE GUIDE OR INTUBATION STYLETTE
K
85
3502
VARIOUS FOME-CUF TRACHEAL TUBES W/SIDEPORT AIRWAY
K
85
2025
BRANDT TRACHEAL TUBE(TENTATIVE)
K
85
2493
UNCUFFED HI-LO JET TRACHEAL TUBE
K
84
4696
TROGIDE
K
84
3988
S.E.T. TUBE
K
84
4564
ARGYLE LASER RESISTANT TRACHEAL TUBE W/MURPHY EYE
K
84
4746
TRACHEAL TUBE W/AIRWAY INTUBATOR
K
84
3936
MONTGOMERY SAFE-T-TUBE
K
84
4296
TRACHEAL TUBE, REINFORCED, CUFFED
K
84
3714
DOUBLE CONTOURED CUFF TRACHEAL TUBE
K
84
1872
UNCUFFED REINFORCED TRACHEAL TUBE
K
84
2635
SHERIDAN/ENDO-PAK
K
84
2558
SHERIDAN/INTENSA TUBE
K
84
2464
TRACHEAL TUBE/STETHOSCOPE
K
84
0943
ENDO-JECT
K
84
0973
COLE TUBE-LATEX
K
83
3831
3-DAY BIOINDICATOR RELEASE FOR STERIL
K
83
3807
ARGYLE JET TRACHEAL TUBE
K
83
3197
TRACH SWIVE/CONNECTOR
K
83
2629
INTUBATION KIT
K
83
0631
TRACHEAL TUBE W/ILLUMINATING LOCATER
K
82
3757
SURGITEK ENDOTRACHEAL TUBE, LASER RESIS
K
83
0504
SURGITEK ULTRA-LO CUFF
K
83
0352
REINFORCED SILICONE TRACHEAL TUBE
K
82
2082
SHERIDAN/HVT,CF, UNCUFFED
K
82
1670
ARGYLE TARTAN I TRACHEAL TUBE
K
82
1456
ENDOTRACHEAL TUBE
K
82
1243
ENDOTRACHEAL TUBE
K
82
1180
TRACELON
K
82
1027
SOFT TIP LOW PRESSURE CUFFED ORAL/NASAL
K
81
3373
VYGON ENDOTRACHEAL TUBES
K
81
2880
OHIO NON-REUSABLE TRACHEAL TUBE MAJILL
K
81
2879
OHIO NON-REUSABLE TRACHEAL TUBE MURPHY
K
81
2943
SLICK ENDOTRACHEAL TUBE
K
81
1937
ARGYLE TARTAN TRACHEAL TUBE
K
81
1888
LINDHOLM ANATOMICAL TRACHEAL TUBE
K
81
0763
OHIO DISPOSABLE TRACHEAL TUBE
K
80
2505
DOUBLE LUMEN TRACHEAL TUBE
K
81
0151
SLICK SET W/SURELOC EXTERNAL CONNECTOR
K
80
1213
CONCEPT ENDOTRACHEAL TUBE
K
80
1005
MLT TUBE MICROLARYNGEAL TRACHEAL TUBE)
K
80
0634
OHIO DISPOSABLE TRACHEAL TUBE
K
79
2035
FOME-CUF-WIRE RE-ENFORCED, AIRE-CUF WIRE
K
79
1046
ENDOTRACHEAL TUBES, LONG & SHORT TERM
K
79
1045
MODEL GV-10 LANZ PRESSURE-VALVE
K
79
0927
OXYGENERATOR NO. M-049
K
79
0575
TUBE, ARMORED TRACHEAL
K
79
0312
ENDOTRACHEAL TUBE W/HOLDER & CONNECTOR
K
78
1713
ADAPTER, C/D SUCTION
K
78
1808
SLICK SET, CUFFED
K
78
1339
ENDOTRACHEAL TUBE
K
78
0900
SLICK SET
K
78
0583
FOME-CUF PVC
K
77
1197
NORTON ENDOTRACHEAL
K
76
0998
ENDOTRACHAEL TUBE AND HOLDER
BTS
Tube, Bronchial (W/Wo Connector)
BTT
Humidifier, Respiratory Gas, (Direct Patient Interface)
BWB
Forceps, Tube Introduction
BWC
Needle, Emergency Airway
BWF
Spirometer, Therapeutic (Incentive)
BWL
Apparatus, Electronanesthesia
BYD
Condenser, Heat And Moisture (Artificial Nose)
BYE
Attachment, Breathing, Positive End Expiratory Pressure
BYF
Mask, Oxygen, Low Concentration, Venturi
BYG
Mask, Oxygen
BYH
Drain, Tee (Water Trap)
BYI
Percussor, Powered-Electric
BYJ
Unit, Liquid-Oxygen, Portable
BYK
Tent, Oxygen, Electrically Powered
BYL
Tent, Oxygen
BYN
Chair, Posture, For Cardiac And Pulmonary Treatment
BYO
Bottle, Blow
BYP
Mouthpiece, Breathing
BYT
Ventilator, External Body, Negative Pressure, Adult (Cuirass)
BYW
Device, Rebreathing
BYX
Tubing, Pressure And Accessories
BZA
Connector, Airway (Extension)
BZB
Catheter, Nasal, Oxygen
BZD
Ventilator, Non-Continuous (Respirator)
BZE
Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer
BZO
Set, Tubing And Support, Ventilator (W Harness)
BZR
Mixer, Breathing Gases, Anesthesia Inhalation
CAD
Vaporizer, Anesthesia, Non-Heated
CAE
Airway, Oropharyngeal, Anesthesiology
CAF
Nebulizer (Direct Patient Interface)
CAG
Circulator, Breathing-Circuit
CAI
Circuit, Breathing (W Connector, Adaptor, Y Piece)
CAL
Laryngoscope, Non-Rigid
CAO
Airway, Esophageal (Obturator)
CAT
Cannula, Nasal, Oxygen
CAW
Generator, Oxygen, Portable
CAZ
Anesthesia Conduction Kit
CBF
Chamber, Hyperbaric
CBG
Spreader, Cuff
CBH
Device, Fixation, Tracheal Tube
CBI
Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)
CBK
Ventilator, Continuous, Facility Use
CBL
Absorbent, Carbon-Dioxide
CBN
Apparatus, Gas-Scavenging
CBO
Attachment, Intermittent Mandatory Ventilation (Imv)
CBP
Valve, Non-Rebreathing
MOD
Accessory To Continuous Ventilator (Respirator)
CCO
Bed, Rocking, Breathing Assist
CCQ
Nebulizer, Medicinal, Non-Ventilatory (Atomizer)
CCT
Applicator (Laryngo-Tracheal), Topical Anesthesia
CCW
Laryngoscope, Rigid
EPE
Brush, Cleaning, Tracheal Tube
FNC
Tent, Pediatric Aerosol
FOG
Hood, Oxygen, Infant
JAY
Support, Breathing Tube
JOH
Tube Tracheostomy And Tube Cuff
KFZ
Humidifier, Non-Direct Patient Interface (Home-Use)
KGB
Mask, Oxygen, Non-Rebreathing
KHA
Mask, Scavenging
LNZ
Changer, Tube, Endotracheal
MIA
Needle, Spinal, Short Term
MNS
Ventilator, Continuous, Non-Life-Supporting
MNT
Ventilator, Continuous, Minimal Ventilatory Support, Facility Use
MRN
Apparatus, Nitric Oxide Delivery
MRO
Apparatus, Nitric Oxide, Backup Delivery
MZT
Device, Heimlich Maneuver Assist
NFB
Conserver, Oxygen
NHJ
Device, Positive Pressure Breathing, Intermittent
NHK
Resuscitator, Manual, Non Self-Inflating
NMA
Tube, Tracheal, Reprocessed
NMC
Mask, Ventilator, Non-Continuous, Reprocessed
NMR
Needle, Spinal, Short Term, Reprocessed
NNH
Needle, Conduction, Anesthesia, Reprocessed
NOU
Continuous, Ventilator, Home Use
NQY
Ventilator, Continuous, Minimal Ventilatory Support, Home Use
NVO
Spacer, Direct Patient Interface
NVP
Holding Chambers, Direct Patient Interface
NXA
Tracheotomy Care Kit
OBN
Humidifier, Respiratory, Mask (Direct Patient Interface)
OFQ
Anesthesia Kit
OFT
Spinal Epidural Anesthesia Kit
OFU
Spinal Anesthesia Kit
OFV
Regional Anesthesia Kit
OGA
Brachial Plexus Anesthesia Kit
OGB
Caudal Anesthesia Kit
OGC
Continuous Brachial Plexus Block Tray
OGD
Custom Anesthesia Tray
OGE
Epidural Anesthesia Kit
OGF
Glossopharyngeal Anesthesia Kit
OGG
Humidifier Nebulizer Kit
OGH
Laryngoscope Kit
OGI
Nasal Endotracheal Tube Holder Kit
OGJ
Nerve Block Tray
OGL
Oxygen Administration Kit
OLF
Medevac Use Oxygen Generator
ONZ
Mechanical Ventilator
OQU
Airway Monitoring System
PHS
Oral Airway Assist
PMB
External Airway
QAV
High Flow/High Velocity Humidified Oxygen Delivery Device
QBY
Positive Airway Pressure System
QCX
Retrograde Intubation Set
OZR
Intraoral Pressure Gradient Device
QFB
Isocapnic Ventilation Device
Subpart G—Miscellaneous
Cardiovascular
Chemistry
Dental
Ear, Nose, Throat
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
AN
/
subpart-f—therapeutic-devices
/
BTR
/
K170234
View Source
Endotracheal tube; Reinforced Endotracheal tube
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K170234
510(k) Type
Traditional
Applicant
Zhanjiang Star Enterprise Co., Ltd
Country
Taiwan
FDA Decision
Substantially Equivalent
Decision Date
1/17/2018
Days to Decision
357 days
Submission Type
Summary