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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
K
23
2601
BroncTru™ Transbronchial Access Tool
2
Cleared 510(K)
K
23
4113
MiiS Horus Bronchoscope; MiiS Horus Endoscope Display System -Tablet; MiiS Horus Endoscope Display System -Video Box
2
Cleared 510(K)
K
23
2038
BioStar Single Use Transbronchial Aspiration Needle
2
Cleared 510(K)
K
23
3779
LoopView® Single-Use Digital Flexible Bronchoscope (B38, B38-C, B50, B50-C, B58, B58-C), ViewHub® Video Processor (S13)
2
Cleared 510(K)
K
24
0135
Ion™ Endoluminal System (Ion™ Fully Articulating Catheter) (IF1000)
2
Cleared 510(K)
K
23
1107
Bronchoscope System
2
Cleared 510(K)
K
24
0075
FUJIFILM Endoscope Model EB-710XT
2
Cleared 510(K)
K
23
2860
PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical Video Bronchoscope EB11-J10, PENTAX Medical Video Bronchoscope EB15-J10, PENTAX Medical Video Bronchoscope EB19-J10U, PENTAX Medical Ultrasound Video Bronchoscope EB19-J10U
2
Cleared 510(K)
K
23
1970
PENTAX Medical Single Use Video Bronchoscope EB11-S01, PENTAX Medical Single Use Video Bronchoscope EB15-S01, PENTAX Medical Mobile Processor ONE-M, PENTAX Medical Mobile Processor Plug-In ONE-Dock
2
Cleared 510(K)
K
23
3671
Ambu® aScope™ 5 Broncho 4.2/2.2; Ambu® aScope™ 5 Broncho 2.7/1.2; Ambu® aView™ 2 Advance
2
Cleared 510(K)
K
23
2984
Ion Endoluminal System (IF1000)
2
Cleared 510(K)
K
23
1521
Broncho Videoscope System
2
Cleared 510(K)
K
23
2582
Ambu® aScope™ 5 Broncho 4.2/2.2 Sampler Set
2
Cleared 510(K)
K
23
0428
Ambu® aScope™ 5 Broncho 2.7/1.2, Ambu® aScope™ 5 Broncho 4.2/2.2, Ambu® aBox™ 2
2
Cleared 510(K)
K
22
2861
EVIS XI Video System Center Olympus CV-1500, Bronchovideoscope Olympus BF-H1100, Bronchovideoscope Olympus BF-1TH1100
2
Cleared 510(K)
K
22
3299
Ambu® aScope™ 5 Broncho HD 5.0/2.2, Ambu® aScope™ 5 Broncho HD 5.6/2.8, Ambu® aView™ 2 Advance
2
Cleared 510(K)
K
22
3836
Vathin® Video Bronchoscope System
2
Cleared 510(K)
K
23
0948
BFlex™ 2 Slim 3.8 Single-Use Bronchoscope
2
Cleared 510(K)
K
22
2910
Bronchoscope System
2
Cleared 510(K)
K
22
1340
iNod Ultrasound Guided Biopsy Needle (UPN: M00502060), iNod Ultrasound Guidance Console (UPN: M00503210)
2
Cleared 510(K)
K
22
3144
Galaxy System
2
Cleared 510(K)
K
22
3782
Ambu aScope 5 Broncho HD 5.6/2.8 Sampler Set, Ambu aScope 5 Broncho HD 5.0/2.2 Sampler Set
2
Cleared 510(K)
K
21
3235
PENTAX Medical ONE Pulmo Single Use Video Bronchoscope System
2
Cleared 510(K)
K
22
0957
FUJIFILM Endoscope Model EB-710P
2
Cleared 510(K)
K
22
1631
Tracheal Intubation Fiberscope OLYMPUS LF-P, VISERA Tracheal Intubation Videoscope OLYMPUS LF Type V
2
Cleared 510(K)
K
22
1302
Recon Steerable Sheath
2
Cleared 510(K)
K
22
2014
EXALT Model B Single-Use Bronchoscope
2
Cleared 510(K)
K
22
0606
Ambu aScope 5 Broncho HD 5.6/2.8, Ambu aScope 5 Broncho HD 5.0/2.2, Ambu aBox 2
2
Cleared 510(K)
K
21
3782
Single-Use Video Bronchoscopes, Digital Controller
2
Cleared 510(K)
K
22
0399
WiScope Digital Bronchoscope System, WiScope Single-Use Digital Flexible Bronchoscope, WiScope Image System
2
Cleared 510(K)
K
22
0299
Ion Endoluminal System (IF1000)
2
Cleared 510(K)
K
21
3635
Vathin Video Bronchoscope System
2
Cleared 510(K)
K
21
2886
Broncoflex Agile, Broncoflex Vortex, Screeni
2
Cleared 510(K)
K
21
2656
Flexible Intubation Video Endoscope – Sterile (FIVE-S)
2
Cleared 510(K)
K
21
1169
Bronchoscope System
2
Cleared 510(K)
K
21
1947
GlideScope BFlex 2.8 Single-Use Bronchoscope
2
Cleared 510(K)
K
21
0928
PENTAX Medical Video Bronchoscope EB11-J10
2
Cleared 510(K)
K
21
2667
Single Use Guide Sheath Kit-401, K-402
2
Cleared 510(K)
K
21
2048
Ion Endoluminal System (Ion Fully Articulating Catheter), Ion Endoluminal System (Ion Peripheral Vision Probe)
2
Cleared 510(K)
K
21
1030
EXALT Model B Single-Use Bronchoscope (Slim), EXALT Model B Single-Use Bronchoscope (Regular), EXALT Model B Single-Use Bronchoscope (Large), EXALT Monitor
2
Cleared 510(K)
K
21
0379
Broncho Videoscope System
2
Cleared 510(K)
K
21
1493
Monarch Platform
2
Cleared 510(K)
K
21
0883
aScope 4 Broncho Regular Sampler Set 5.0/2.2, aScope 4 Broncho Large Sampler Set 5.8/2.8
2
Cleared 510(K)
K
20
2987
Rescue Pulmonary Grasping Forceps
2
Cleared 510(K)
K
20
2346
SPiN Vision Video Bronchoscope System
2
Cleared 510(K)
K
20
1300
Airway Mobilescope
2
Cleared 510(K)
K
20
1758
EVIS EXERA III Bronchovideoscope Olympus BF-XP190, EVIS EXERA III Bronchovideoscope Olympus BF-P190
2
Cleared 510(K)
K
20
0702
EasyPath RF Introducer Sheath
2
Cleared 510(K)
K
20
0342
Single Use Grasping Forceps FG-214P, Single Use Grasping Forceps FG-220P, Single Use Grasping Forceps FG-226C, Single Use Grasping Forceps FG-232L, Single Use Grasping Forceps FG-804L
2
Cleared 510(K)
K
20
2370
Ion Endoluminal System
2
Cleared 510(K)
K
20
2180
Broncoflex Agile; Product Reference: 20030001 , Broncoflex Vortex; Product Reference: 10030001, Screeni; Product Reference: 30030001
2
Cleared 510(K)
K
20
0678
PENTAX Medical Video Bronchoscope EB-J10 Series
2
Cleared 510(K)
K
20
1146
Ion Endoluminal System
2
Cleared 510(K)
K
20
0397
Single Use Biopsy Forceps FB-456D
2
Cleared 510(K)
K
19
3534
Monarch Platform
2
Cleared 510(K)
K
19
2164
Single Use Guide Sheath Kit K-401, K-402, & Single Use Guiding Device CC-220DR
2
Cleared 510(K)
K
19
1828
Vathin Video Bronchoscope System
2
Cleared 510(K)
K
19
3488
GlideScope BFlex 3.8 Single-Use Bronchoscope
2
Cleared 510(K)
K
19
2367
Ion Endoluminal System
2
Cleared 510(K)
K
18
3516
PENTAX Medical Ultrasound Video Bronchoscope EB19-J10U
2
Cleared 510(K)
K
18
3419
EVIS EXERA III Bronchovideoscope Olympus BF-XT190
2
Cleared 510(K)
K
18
3607
FUJIFILM Bronchoscope
2
Cleared 510(K)
K
19
1948
GlideScope BFlex 5.8 Single-Use Bronchoscope
2
Cleared 510(K)
K
18
3654
PENTAX Medical EB-1970UK Ultrasound Video Bronchoscope + Hitachi NOBLUS and HI VISION Preirus
2
Cleared 510(K)
K
18
2253
FUJIFILM Video Bronchoscopes
2
Cleared 510(K)
K
18
3085
CoreDx™ Pulmonary Mini-Forceps
2
Cleared 510(K)
K
18
2825
FUJIFILM Ultrasonic Endoscope
2
Cleared 510(K)
K
18
2188
Ion Endoluminal System ; Flexision Biopsy Needle
2
Cleared 510(K)
K
18
3256
GlideScope BFlex Single-Use Bronchoscope System
2
Cleared 510(K)
K
17
2726
EVIS EXERA III BRONCHOFIBERVIDEOSCOPE OLYMPUS BF-MP190F, Single Use Biopsy Forceps FB-433D
2
Cleared 510(K)
K
17
2955
LungVision Tool
2
Cleared 510(K)
K
17
3727
Ambu aScope 3 Slim 3.8/1.2 and Ambu aScope 4 Broncho Slim 3.8/1.2; Ambu aScope 3 Regular 5.0/2.2 and Ambu aScope 4 Broncho Regular 5.0/2.2; Ambu aScope 3 Large 5.8/2.8 and Ambu aScope 4 Broncho Large 5.8/2.8; Ambu aView Monitor
2
Cleared 510(K)
K
17
3760
Monarch Endoscopy Platform (Monarch Platform)
2
Cleared 510(K)
K
16
3377
Captura Disposable Bronchoscope Biopsy Forceps
2
Cleared 510(K)
K
17
3554
PENTAX Medical Video Bronchoscopes, PENTAX Medical Video Naso-Pharyngo-Laryngoscope, and PENTAX Medical Ultrasond Video Bronchoscope
2
Cleared 510(K)
K
17
1291
FUJIFILM Bronchoscope Model EB-530P
2
Cleared 510(K)
K
17
1492
B7 2C Occlusion Balloon
2
Cleared 510(K)
K
16
3537
Arcpoint pulmonary needle - 18 ga, Arcpoint pulmonary needle - 21 ga
2
Cleared 510(K)
K
16
3248
Expect Pulmonary Endobronchial Ultrasound Transbronchial Aspiration Needle
2
Cleared 510(K)
K
16
2611
PeriFLEX
2
Cleared 510(K)
K
16
1656
Ambu aScope 3 Regular 5.0/2.2, Ambu aScope 3 Slim 3.8/1.2, Ambu aScope 3 Large 5.8/2.8, Ambu aView Monitor
2
Cleared 510(K)
K
15
2319
Auris Robotic Endoscopy System (ARES)
2
Cleared 510(K)
K
15
2466
Neo-Bronchoscope -Digital Video Bronchoscopy System(Rigid/Flexible)
2
Cleared 510(K)
K
15
1315
Expect Pulmonary Endobronchial Ultrasound Transbronchial Aspiration Needle
2
Cleared 510(K)
K
14
3727
PENTAX Medical EKP-i5010 Video Processor with EB Family
2
Cleared 510(K)
K
14
2934
CrossCountry Transbronchial Access Tool straight, CrossCountry Transbronchial Access Tool curved
2
Cleared 510(K)
K
15
0280
PulmoVia Working Channel
2
Cleared 510(K)
K
14
2839
GenCut Core Biopsy System
2
Cleared 510(K)
K
14
2909
Flexible 19G EBUS Needle
2
Cleared 510(K)
K
14
1366
VIDEO BRONCHOSCOPE SYSTEM
2
Cleared 510(K)
K
13
1946
ENTAX ULTRASOUND VIDEO BRONCHOSCOPE EB-1970UK + HI VISIN PREIRUS
2
Cleared 510(K)
K
13
1028
PENTAX VIDEO BRONCHOSCOPES (EB FAMILY)
2
Cleared 510(K)
K
13
0845
AMBU ASCOPE 3 5.0/2.2; AMBU ASCOPE 3 SLIM 3.8/1.2; AMBU AVIEW
2
Cleared 510(K)
K
13
1234
LUNGPOINT TOOLS (LUNGPOINT SHEATH, LUNGPOINT DILATION BALLOON)
2
Cleared 510(K)
K
13
1401
BLOWFISH TRANSBRONCHIAL MICRO-INFUSION CATHETER
2
Cleared 510(K)
K
12
1959
EVIS EXERA III VIDEO SYSTEM
2
Cleared 510(K)
K
12
2535
FUJINON/FUJIFILM EB-530 SERIES BRONCHOSCOPES (EB-530S, EB-530T AND EB-530H
2
Cleared 510(K)
K
12
1035
FUJINON/FUJIFILM ULTRASONIC ENDOSCOPE EB-530US
2
Cleared 510(K)
K
09
1768
VIDEO SCIENCES BRS-5000 VIDEO BRONCHOSCOPE WITH ENDOSHEATH SYSTEM, DPU-5000/DPU-5050 VIDEO PROCESSOR & ACCESSORIES
2
Cleared 510(K)
K
09
1250
DIAGNOSTIC CATHETER SYSTEM
2
Cleared 510(K)
K
09
0853
YIELD TISSUE SAMPLER
2
Cleared 510(K)
K
08
2720
TRACHEAL INTUBATION FIBERVIDEOSCOPE, MODELS LF-Y0004 AND LF-Y0005
2
Cleared 510(K)
K
08
1518
ULTRASOUND VIDEO BRONCHOSCOPE, MODEL EB-1970UK
2
Cleared 510(K)
K
07
1530
KARL STORZ VIDEO FLEXIBLE VIDEO ENT ENDOSCOPE SYSTEM
2
Cleared 510(K)
K
07
1473
MODIFICATION TO SUPERDIMENSION/BRONCHUS PREMIUM 2
2
Cleared 510(K)
K
06
1313
EVIS EXERA 180 SYSTEM
2
Cleared 510(K)
K
06
0243
OLYMPUS GUIDE SHEATH, MODEL XBO1-836-13
2
Cleared 510(K)
K
05
0907
FUJINON G5 BRONCHOSCOPES, MODELS EB-470S, EB-250S, AND EB-270P
2
Cleared 510(K)
K
05
0220
EVIS EXERA BRONCHOVIDEOSCOPE, OLYMPUS XBF-160Y3AC, XBF-1T160Y3AC,XBF-Q160Y2AC
2
Cleared 510(K)
K
04
0940
BRONCHOVIDEOSCOPE OLYMPUS XBF-D160HM
2
Cleared 510(K)
K
04
0018
EXCELON TRANSBRONCHIAL ASPIRATION NEEDLE, MODELS 6410, 6411, 6412
2
Cleared 510(K)
K
03
3225
EVIS EXERA BRONCHOFIBERVIDEOSCOPE OLYMPUS BF TYPE XP160F, ITS ACCESSORIES AND ANCILLARY EQUIPMENT
2
Cleared 510(K)
K
03
1966
ENK FIBEROPTIC ATOMIZER SET
2
Cleared 510(K)
K
02
2446
MUCUS COLLECTION PROBE, MODELS BC-401C & BC-402C
2
Cleared 510(K)
K
02
3984
MODIFICATION TO OLYMPUS BRONCHOSCOPES BF-40 SERIES, BF-240 SERIES, AND BF-160 SERIES
2
Cleared 510(K)
K
02
4165
DUAL-LUMEN CATHETER
2
Cleared 510(K)
K
02
3376
EB-1830T3, VIDEO BRONCHOSCOPE
2
Cleared 510(K)
K
02
2546
HORIZONS ANSO TRANSBRONCHIAL ASPIRATION NEEDLES
2
Cleared 510(K)
K
02
1344
B-F200 BRONCHOSCOPE WITH BSS-F21 ENDOSHEATH SYSTEM
2
Cleared 510(K)
K
01
3731
GIMMI ALPHA SINUSCOPES MODEL # E.8282.01/31/71 + E.8284.01/31/71; GIMMI ALPHA BRONCHOSCOPES MODEL # E.8189.00/01/02/03
2
Cleared 510(K)
K
01
3111
EXHALE PROBE
2
Cleared 510(K)
K
01
2073
OLYMPUS SPRAY CATHETER PW-6C-1
2
Cleared 510(K)
K
01
1267
EXHALE RF PROBE
2
Cleared 510(K)
K
99
3900
COAGULATION ELECTRODE, MODEL 2000; RADIOFREQUENCY GENERATOR, MODEL 20-115
2
Cleared 510(K)
K
99
0547
PILLING WECK SURGICAL Y STENT FORCEPS
2
Cleared 510(K)
K
98
3878
CZAJA-MCCAFFREY RIGID STENT INTRODUCER/ENDOSCOPE
2
Cleared 510(K)
K
98
4157
MODIFICATION TO WILSON-COOK LUNG BIOPSY NEEDLE
2
Cleared 510(K)
K
98
3124
MILL-ROSE LABORATORIES TRANSBRONCHIAL NEEDLE ASPIRATION (TBNA) CYTOLOGY PROCEDURAL KIT
2
Cleared 510(K)
K
98
3122
MILL-ROSE LABORATORIES TRANSBRONCHIAL NEEDLE ASPIRATION (TBNA) COMBINATION CYTOLOGY/HISTOLOGY PROCEDURAL KIT
2
Cleared 510(K)
K
98
2983
LSVP INTERNATIONAL BIOPSY FORCEPS
2
Cleared 510(K)
K
98
1543
OLYMPUS LF-TP AND LF-DP TRACHEAL INTUBATION FIBERSCOPES, ACCESSORIES AND ANCILLARY EQUIPMENT
2
Cleared 510(K)
K
98
0046
BRONCHIAL CATHETER SYSTEM
2
Cleared 510(K)
K
97
4642
COMBICATH CATHETER
2
Cleared 510(K)
K
97
0107
INTUBATION ENDOSCOPE AND INTRODUCER SHEATH
2
Cleared 510(K)
K
96
3795
VISION-SCIENCES MODEL B-F100 BRONCHOSCOPE WITH MODEL BS-F21 DISPOSABLE ENDOSHEATH
2
Cleared 510(K)
K
96
3252
TBAN
2
Cleared 510(K)
K
96
3033
BF 240/P240/IT240 BRONCHOVIDEOSCOPE & ACCESSORIES
2
Cleared 510(K)
K
96
2901
OLYMPUS B5-2C/B7-2C BALLOON CATHETER
2
Cleared 510(K)
K
96
2485
OLYMPUS FG SERIES OF RAT TOOTH GRASPING FORCEPS (ENT)
2
Cleared 510(K)
K
96
2533
OLYPUS FG SERIES GRASPING FORCEPS
2
Cleared 510(K)
K
96
2380
OLYMPUS BF TYPE 200 VIDEO BRONCHSCOPES(BF-200/BF-P200/BF-IT200)
2
Cleared 510(K)
K
96
2367
OLYMPUS BASKET GRASPERS
2
Cleared 510(K)
K
96
2378
OLYMPUS FG-45/46-1 GRASPING FORCEPS
2
Cleared 510(K)
K
96
2555
OLYMPUS FB SERIES BIOPSY FORCEPS
2
Cleared 510(K)
K
96
2736
MILL-ROSE LARYNGOSCOPIC INJECTION NEEDLE
2
Cleared 510(K)
K
96
1178
KARL STORZ INTUBATION FIBERSCOPE
2
Cleared 510(K)
K
96
0880
MILL-ROSE BLIND MICROBIOLOGY BRUSH
2
Cleared 510(K)
K
96
0791
KARL STORZ HUZLY HIGH-FREQUENCY CUTTING LOOPS
2
Cleared 510(K)
K
95
4797
KARL STORZ RHINO-LARYNGO-BRONCHO FIBERSCOPE, FIBERSCOPE FOR BRONCHOSCOPY
2
Cleared 510(K)
K
94
5268
OPTUS BRONCHOSCOPES
2
Cleared 510(K)
K
95
4707
BRONCHOSCOPE
2
Cleared 510(K)
K
95
4125
SAUER ENDOSCOPE GUIDE AND INTUBATION AID
2
Cleared 510(K)
K
95
3596
DISTENDING DIVERTICULOSCOPE
2
Cleared 510(K)
K
95
0925
JEDMED LARYNGEAL SCOPE
2
Cleared 510(K)
K
95
2081
KARL STORZ CATHETERS, ADAPTORS, SUCTION/IRRIGATION CATHETERS, TUBING
2
Cleared 510(K)
K
95
1826
KARL STORZ TRACHEAL HIGH FREQUENCY RESECTOSCOPE
2
Cleared 510(K)
K
95
1199
FB-18X, FIBER BRONCHOSCOPE
2
Cleared 510(K)
K
95
0965
KARL STORZ STENT APPLICATOR FORCEPS
2
Cleared 510(K)
K
95
1051
RITE-BITE BIOPSY FORCEPS
2
Cleared 510(K)
K
95
0786
OLYMPUS BIOPSY FORCEPS MODEL FB-44
2
Cleared 510(K)
K
95
0636
OLYMPUS DISPOSABLE BIOPSY FORCEPS
2
Cleared 510(K)
K
93
1442
11274 AB FLEXIBLE PEDIATRIC BRONCHOSCOPE
2
Cleared 510(K)
K
94
4976
BRONCHOSCOPE,NON-RIGID
2
Cleared 510(K)
K
94
4649
MILL-ROSE HARRELL BRONCHIAL BRUSH
2
Cleared 510(K)
K
94
4650
WANG BRONCHIAL NEEDLE BRUSH
2
Cleared 510(K)
K
94
3700
KARL STORZ BRONCHOSCOPE ACCESSORIES
2
Cleared 510(K)
K
94
2388
TAS-(VARIOUS) ULTRATHIN FLEXIBLE ENDOSCOPE
2
Cleared 510(K)
K
94
1264
RICHARD ROD LENS LARYNGOSCOPE
2
Cleared 510(K)
K
94
1161
FLEXIBLE GRASPING FORCEPS
2
Cleared 510(K)
K
94
0521
MILL-ROSE PROTECTED TRANSLARYNGOSCOPIC CATHETER
2
Cleared 510(K)
K
94
1158
FLEXIBLE BIOPSY CUP FORCEPS
2
Cleared 510(K)
K
93
4920
VB-1830/VB-1530, VIDEO BRONCHOSCOPE
2
Cleared 510(K)
K
93
3433
MODIFIED BRONCHOSCOPE AND ACCESSORIES
2
Cleared 510(K)
K
93
1154
EVIS 200 SYSTEM
2
Cleared 510(K)
K
92
2204
MILL-ROSE PULMONARY FORCEPS
2
Cleared 510(K)
K
92
6430
CANNULATED BIOPSY FORCEPS
2
Cleared 510(K)
K
92
3847
DISPOSABLE BRONCHOSCOPE BIOPSY FORCEPS
2
Cleared 510(K)
K
92
2937
FLEXIBLE FIBER OPTIC ENDOSCOPE
2
Cleared 510(K)
K
92
1393
IMAGICA MICRO-ENDOSCOPE
2
Cleared 510(K)
K
91
5816
BITE BLOCK/MOUTHPIECE FOR ENDOSCOPY
2
Cleared 510(K)
K
92
0025
OLYMPUS DISPOSABLE SUCTION VALVE
2
Cleared 510(K)
K
91
4181
WANG/MILL-ROSE TRANSBRONCHIAL ASPIRATION NEEDLE
2
Cleared 510(K)
K
91
0536
PROTECTED BRONCHOALVEOLAR LAVAGE BALLOON CATHETER
2
Cleared 510(K)
K
91
1922
BRONCHOSCOPE ACCESSORY, NSN 6515-00-315-2200
2
Cleared 510(K)
K
91
1412
OLYMPUS DISPOSABLE BIOPSY VALVE
2
Cleared 510(K)
K
91
0423
BRONCHOSCOPE BF-N20
2
Cleared 510(K)
K
89
5948
PORT-O-SCOPE(TM)
2
Cleared 510(K)
K
89
6146
BIOPSY FORCEPS, (NON-RIGID)
2
Cleared 510(K)
K
89
3006
EXMOOR BITE BUFFER
2
Cleared 510(K)
K
89
5415
BIOPSY FORCEPS
2
Cleared 510(K)
K
89
2687
CANNULATED BIOPSY FORCEPS
2
Cleared 510(K)
K
87
0063
CO2 LASER BRONCHOSCOPE SET
2
Cleared 510(K)
K
86
2835
CO2 FIBEROPTIC DELIVERY SYSTEM/BRONCHOSCOPIC USE
2
Cleared 510(K)
K
85
4414
DUMON/HARRELL
2
Cleared 510(K)
K
85
4581
MACHIDA SEMI-RIGID BRONCHOSCOPE FBS-6R-50
2
Cleared 510(K)
K
84
4834
MACHIDA FLEXIBLE NASOPHARYNGO-LARYNGOSCOPE FNS-1
2
Cleared 510(K)
K
83
3483
ENDOSCOPIC COUPLER
2
Cleared 510(K)
K
83
2492
BRONCHO FIBERSCOPE FB-19C
2
Cleared 510(K)
K
83
2449
LARYNGOTELESCOPE CURVED MLC-1
2
Cleared 510(K)
K
83
2010
BRONCHO-FIBERSCOPE
2
Cleared 510(K)
K
83
1240
LASER BRONCHOSCOPE
2
Cleared 510(K)
K
82
2844
PENTAX BRONCHOFIBERSCOPE #FB-19E
2
Cleared 510(K)
K
82
2257
VARIOUS TYPES OF LIGHT SOURCE HANDLES
2
Cleared 510(K)
K
82
2180
RIGID FIBEROPTIC ENDOSCOPES
2
Cleared 510(K)
K
82
2136
LASER BRONCHOSCOPE
2
Cleared 510(K)
K
81
1218
ACMI ASPIRATOR KIT #8808
2
Cleared 510(K)
K
81
1059
PENTAX BRONCHOFIBERSCOPE #FB-15A
2
Cleared 510(K)
K
81
1181
MODEL FBS-1, FLEXIBLE BRONCHOSCOPE
2
Cleared 510(K)
K
79
2342
PENTAX BROCHOFIBERSCOPE MODEL FB-17D,
2
Cleared 510(K)
K
79
2267
PENTEX BRONCHOFIBERSCOPE MODEL FB-17A
2
Cleared 510(K)
K
77
0500
3 PORT LUER
2
Cleared 510(K)
K
76
0171
FIBERBRONCHOSCOPE (PENTAX FB-17A)
2
Cleared 510(K)
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
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
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—surgical-devices
/
EOQ
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K213635
View Source
Vathin Video Bronchoscope System
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K213635
510(k) Type
Traditional
Applicant
Hunan Vathin Medical Instrument Co., Ltd.
Country
China
FDA Decision
Substantially Equivalent
Decision Date
2/28/2022
Days to Decision
103 days
Submission Type
Statement
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)
K
23
2601
BroncTru™ Transbronchial Access Tool
K
23
4113
MiiS Horus Bronchoscope; MiiS Horus Endoscope Display System -Tablet; MiiS Horus Endoscope Display System -Video Box
K
23
2038
BioStar Single Use Transbronchial Aspiration Needle
K
23
3779
LoopView® Single-Use Digital Flexible Bronchoscope (B38, B38-C, B50, B50-C, B58, B58-C), ViewHub® Video Processor (S13)
K
24
0135
Ion™ Endoluminal System (Ion™ Fully Articulating Catheter) (IF1000)
K
23
1107
Bronchoscope System
K
24
0075
FUJIFILM Endoscope Model EB-710XT
K
23
2860
PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical Video Bronchoscope EB11-J10, PENTAX Medical Video Bronchoscope EB15-J10, PENTAX Medical Video Bronchoscope EB19-J10U, PENTAX Medical Ultrasound Video Bronchoscope EB19-J10U
K
23
1970
PENTAX Medical Single Use Video Bronchoscope EB11-S01, PENTAX Medical Single Use Video Bronchoscope EB15-S01, PENTAX Medical Mobile Processor ONE-M, PENTAX Medical Mobile Processor Plug-In ONE-Dock
K
23
3671
Ambu® aScope™ 5 Broncho 4.2/2.2; Ambu® aScope™ 5 Broncho 2.7/1.2; Ambu® aView™ 2 Advance
K
23
2984
Ion Endoluminal System (IF1000)
K
23
1521
Broncho Videoscope System
K
23
2582
Ambu® aScope™ 5 Broncho 4.2/2.2 Sampler Set
K
23
0428
Ambu® aScope™ 5 Broncho 2.7/1.2, Ambu® aScope™ 5 Broncho 4.2/2.2, Ambu® aBox™ 2
K
22
2861
EVIS XI Video System Center Olympus CV-1500, Bronchovideoscope Olympus BF-H1100, Bronchovideoscope Olympus BF-1TH1100
K
22
3299
Ambu® aScope™ 5 Broncho HD 5.0/2.2, Ambu® aScope™ 5 Broncho HD 5.6/2.8, Ambu® aView™ 2 Advance
K
22
3836
Vathin® Video Bronchoscope System
K
23
0948
BFlex™ 2 Slim 3.8 Single-Use Bronchoscope
K
22
2910
Bronchoscope System
K
22
1340
iNod Ultrasound Guided Biopsy Needle (UPN: M00502060), iNod Ultrasound Guidance Console (UPN: M00503210)
K
22
3144
Galaxy System
K
22
3782
Ambu aScope 5 Broncho HD 5.6/2.8 Sampler Set, Ambu aScope 5 Broncho HD 5.0/2.2 Sampler Set
K
21
3235
PENTAX Medical ONE Pulmo Single Use Video Bronchoscope System
K
22
0957
FUJIFILM Endoscope Model EB-710P
K
22
1631
Tracheal Intubation Fiberscope OLYMPUS LF-P, VISERA Tracheal Intubation Videoscope OLYMPUS LF Type V
K
22
1302
Recon Steerable Sheath
K
22
2014
EXALT Model B Single-Use Bronchoscope
K
22
0606
Ambu aScope 5 Broncho HD 5.6/2.8, Ambu aScope 5 Broncho HD 5.0/2.2, Ambu aBox 2
K
21
3782
Single-Use Video Bronchoscopes, Digital Controller
K
22
0399
WiScope Digital Bronchoscope System, WiScope Single-Use Digital Flexible Bronchoscope, WiScope Image System
K
22
0299
Ion Endoluminal System (IF1000)
K
21
3635
Vathin Video Bronchoscope System
K
21
2886
Broncoflex Agile, Broncoflex Vortex, Screeni
K
21
2656
Flexible Intubation Video Endoscope – Sterile (FIVE-S)
K
21
1169
Bronchoscope System
K
21
1947
GlideScope BFlex 2.8 Single-Use Bronchoscope
K
21
0928
PENTAX Medical Video Bronchoscope EB11-J10
K
21
2667
Single Use Guide Sheath Kit-401, K-402
K
21
2048
Ion Endoluminal System (Ion Fully Articulating Catheter), Ion Endoluminal System (Ion Peripheral Vision Probe)
K
21
1030
EXALT Model B Single-Use Bronchoscope (Slim), EXALT Model B Single-Use Bronchoscope (Regular), EXALT Model B Single-Use Bronchoscope (Large), EXALT Monitor
K
21
0379
Broncho Videoscope System
K
21
1493
Monarch Platform
K
21
0883
aScope 4 Broncho Regular Sampler Set 5.0/2.2, aScope 4 Broncho Large Sampler Set 5.8/2.8
K
20
2987
Rescue Pulmonary Grasping Forceps
K
20
2346
SPiN Vision Video Bronchoscope System
K
20
1300
Airway Mobilescope
K
20
1758
EVIS EXERA III Bronchovideoscope Olympus BF-XP190, EVIS EXERA III Bronchovideoscope Olympus BF-P190
K
20
0702
EasyPath RF Introducer Sheath
K
20
0342
Single Use Grasping Forceps FG-214P, Single Use Grasping Forceps FG-220P, Single Use Grasping Forceps FG-226C, Single Use Grasping Forceps FG-232L, Single Use Grasping Forceps FG-804L
K
20
2370
Ion Endoluminal System
K
20
2180
Broncoflex Agile; Product Reference: 20030001 , Broncoflex Vortex; Product Reference: 10030001, Screeni; Product Reference: 30030001
K
20
0678
PENTAX Medical Video Bronchoscope EB-J10 Series
K
20
1146
Ion Endoluminal System
K
20
0397
Single Use Biopsy Forceps FB-456D
K
19
3534
Monarch Platform
K
19
2164
Single Use Guide Sheath Kit K-401, K-402, & Single Use Guiding Device CC-220DR
K
19
1828
Vathin Video Bronchoscope System
K
19
3488
GlideScope BFlex 3.8 Single-Use Bronchoscope
K
19
2367
Ion Endoluminal System
K
18
3516
PENTAX Medical Ultrasound Video Bronchoscope EB19-J10U
K
18
3419
EVIS EXERA III Bronchovideoscope Olympus BF-XT190
K
18
3607
FUJIFILM Bronchoscope
K
19
1948
GlideScope BFlex 5.8 Single-Use Bronchoscope
K
18
3654
PENTAX Medical EB-1970UK Ultrasound Video Bronchoscope + Hitachi NOBLUS and HI VISION Preirus
K
18
2253
FUJIFILM Video Bronchoscopes
K
18
3085
CoreDx™ Pulmonary Mini-Forceps
K
18
2825
FUJIFILM Ultrasonic Endoscope
K
18
2188
Ion Endoluminal System ; Flexision Biopsy Needle
K
18
3256
GlideScope BFlex Single-Use Bronchoscope System
K
17
2726
EVIS EXERA III BRONCHOFIBERVIDEOSCOPE OLYMPUS BF-MP190F, Single Use Biopsy Forceps FB-433D
K
17
2955
LungVision Tool
K
17
3727
Ambu aScope 3 Slim 3.8/1.2 and Ambu aScope 4 Broncho Slim 3.8/1.2; Ambu aScope 3 Regular 5.0/2.2 and Ambu aScope 4 Broncho Regular 5.0/2.2; Ambu aScope 3 Large 5.8/2.8 and Ambu aScope 4 Broncho Large 5.8/2.8; Ambu aView Monitor
K
17
3760
Monarch Endoscopy Platform (Monarch Platform)
K
16
3377
Captura Disposable Bronchoscope Biopsy Forceps
K
17
3554
PENTAX Medical Video Bronchoscopes, PENTAX Medical Video Naso-Pharyngo-Laryngoscope, and PENTAX Medical Ultrasond Video Bronchoscope
K
17
1291
FUJIFILM Bronchoscope Model EB-530P
K
17
1492
B7 2C Occlusion Balloon
K
16
3537
Arcpoint pulmonary needle - 18 ga, Arcpoint pulmonary needle - 21 ga
K
16
3248
Expect Pulmonary Endobronchial Ultrasound Transbronchial Aspiration Needle
K
16
2611
PeriFLEX
K
16
1656
Ambu aScope 3 Regular 5.0/2.2, Ambu aScope 3 Slim 3.8/1.2, Ambu aScope 3 Large 5.8/2.8, Ambu aView Monitor
K
15
2319
Auris Robotic Endoscopy System (ARES)
K
15
2466
Neo-Bronchoscope -Digital Video Bronchoscopy System(Rigid/Flexible)
K
15
1315
Expect Pulmonary Endobronchial Ultrasound Transbronchial Aspiration Needle
K
14
3727
PENTAX Medical EKP-i5010 Video Processor with EB Family
K
14
2934
CrossCountry Transbronchial Access Tool straight, CrossCountry Transbronchial Access Tool curved
K
15
0280
PulmoVia Working Channel
K
14
2839
GenCut Core Biopsy System
K
14
2909
Flexible 19G EBUS Needle
K
14
1366
VIDEO BRONCHOSCOPE SYSTEM
K
13
1946
ENTAX ULTRASOUND VIDEO BRONCHOSCOPE EB-1970UK + HI VISIN PREIRUS
K
13
1028
PENTAX VIDEO BRONCHOSCOPES (EB FAMILY)
K
13
0845
AMBU ASCOPE 3 5.0/2.2; AMBU ASCOPE 3 SLIM 3.8/1.2; AMBU AVIEW
K
13
1234
LUNGPOINT TOOLS (LUNGPOINT SHEATH, LUNGPOINT DILATION BALLOON)
K
13
1401
BLOWFISH TRANSBRONCHIAL MICRO-INFUSION CATHETER
K
12
1959
EVIS EXERA III VIDEO SYSTEM
K
12
2535
FUJINON/FUJIFILM EB-530 SERIES BRONCHOSCOPES (EB-530S, EB-530T AND EB-530H
K
12
1035
FUJINON/FUJIFILM ULTRASONIC ENDOSCOPE EB-530US
K
09
1768
VIDEO SCIENCES BRS-5000 VIDEO BRONCHOSCOPE WITH ENDOSHEATH SYSTEM, DPU-5000/DPU-5050 VIDEO PROCESSOR & ACCESSORIES
K
09
1250
DIAGNOSTIC CATHETER SYSTEM
K
09
0853
YIELD TISSUE SAMPLER
K
08
2720
TRACHEAL INTUBATION FIBERVIDEOSCOPE, MODELS LF-Y0004 AND LF-Y0005
K
08
1518
ULTRASOUND VIDEO BRONCHOSCOPE, MODEL EB-1970UK
K
07
1530
KARL STORZ VIDEO FLEXIBLE VIDEO ENT ENDOSCOPE SYSTEM
K
07
1473
MODIFICATION TO SUPERDIMENSION/BRONCHUS PREMIUM 2
K
06
1313
EVIS EXERA 180 SYSTEM
K
06
0243
OLYMPUS GUIDE SHEATH, MODEL XBO1-836-13
K
05
0907
FUJINON G5 BRONCHOSCOPES, MODELS EB-470S, EB-250S, AND EB-270P
K
05
0220
EVIS EXERA BRONCHOVIDEOSCOPE, OLYMPUS XBF-160Y3AC, XBF-1T160Y3AC,XBF-Q160Y2AC
K
04
0940
BRONCHOVIDEOSCOPE OLYMPUS XBF-D160HM
K
04
0018
EXCELON TRANSBRONCHIAL ASPIRATION NEEDLE, MODELS 6410, 6411, 6412
K
03
3225
EVIS EXERA BRONCHOFIBERVIDEOSCOPE OLYMPUS BF TYPE XP160F, ITS ACCESSORIES AND ANCILLARY EQUIPMENT
K
03
1966
ENK FIBEROPTIC ATOMIZER SET
K
02
2446
MUCUS COLLECTION PROBE, MODELS BC-401C & BC-402C
K
02
3984
MODIFICATION TO OLYMPUS BRONCHOSCOPES BF-40 SERIES, BF-240 SERIES, AND BF-160 SERIES
K
02
4165
DUAL-LUMEN CATHETER
K
02
3376
EB-1830T3, VIDEO BRONCHOSCOPE
K
02
2546
HORIZONS ANSO TRANSBRONCHIAL ASPIRATION NEEDLES
K
02
1344
B-F200 BRONCHOSCOPE WITH BSS-F21 ENDOSHEATH SYSTEM
K
01
3731
GIMMI ALPHA SINUSCOPES MODEL # E.8282.01/31/71 + E.8284.01/31/71; GIMMI ALPHA BRONCHOSCOPES MODEL # E.8189.00/01/02/03
K
01
3111
EXHALE PROBE
K
01
2073
OLYMPUS SPRAY CATHETER PW-6C-1
K
01
1267
EXHALE RF PROBE
K
99
3900
COAGULATION ELECTRODE, MODEL 2000; RADIOFREQUENCY GENERATOR, MODEL 20-115
K
99
0547
PILLING WECK SURGICAL Y STENT FORCEPS
K
98
3878
CZAJA-MCCAFFREY RIGID STENT INTRODUCER/ENDOSCOPE
K
98
4157
MODIFICATION TO WILSON-COOK LUNG BIOPSY NEEDLE
K
98
3124
MILL-ROSE LABORATORIES TRANSBRONCHIAL NEEDLE ASPIRATION (TBNA) CYTOLOGY PROCEDURAL KIT
K
98
3122
MILL-ROSE LABORATORIES TRANSBRONCHIAL NEEDLE ASPIRATION (TBNA) COMBINATION CYTOLOGY/HISTOLOGY PROCEDURAL KIT
K
98
2983
LSVP INTERNATIONAL BIOPSY FORCEPS
K
98
1543
OLYMPUS LF-TP AND LF-DP TRACHEAL INTUBATION FIBERSCOPES, ACCESSORIES AND ANCILLARY EQUIPMENT
K
98
0046
BRONCHIAL CATHETER SYSTEM
K
97
4642
COMBICATH CATHETER
K
97
0107
INTUBATION ENDOSCOPE AND INTRODUCER SHEATH
K
96
3795
VISION-SCIENCES MODEL B-F100 BRONCHOSCOPE WITH MODEL BS-F21 DISPOSABLE ENDOSHEATH
K
96
3252
TBAN
K
96
3033
BF 240/P240/IT240 BRONCHOVIDEOSCOPE & ACCESSORIES
K
96
2901
OLYMPUS B5-2C/B7-2C BALLOON CATHETER
K
96
2485
OLYMPUS FG SERIES OF RAT TOOTH GRASPING FORCEPS (ENT)
K
96
2533
OLYPUS FG SERIES GRASPING FORCEPS
K
96
2380
OLYMPUS BF TYPE 200 VIDEO BRONCHSCOPES(BF-200/BF-P200/BF-IT200)
K
96
2367
OLYMPUS BASKET GRASPERS
K
96
2378
OLYMPUS FG-45/46-1 GRASPING FORCEPS
K
96
2555
OLYMPUS FB SERIES BIOPSY FORCEPS
K
96
2736
MILL-ROSE LARYNGOSCOPIC INJECTION NEEDLE
K
96
1178
KARL STORZ INTUBATION FIBERSCOPE
K
96
0880
MILL-ROSE BLIND MICROBIOLOGY BRUSH
K
96
0791
KARL STORZ HUZLY HIGH-FREQUENCY CUTTING LOOPS
K
95
4797
KARL STORZ RHINO-LARYNGO-BRONCHO FIBERSCOPE, FIBERSCOPE FOR BRONCHOSCOPY
K
94
5268
OPTUS BRONCHOSCOPES
K
95
4707
BRONCHOSCOPE
K
95
4125
SAUER ENDOSCOPE GUIDE AND INTUBATION AID
K
95
3596
DISTENDING DIVERTICULOSCOPE
K
95
0925
JEDMED LARYNGEAL SCOPE
K
95
2081
KARL STORZ CATHETERS, ADAPTORS, SUCTION/IRRIGATION CATHETERS, TUBING
K
95
1826
KARL STORZ TRACHEAL HIGH FREQUENCY RESECTOSCOPE
K
95
1199
FB-18X, FIBER BRONCHOSCOPE
K
95
0965
KARL STORZ STENT APPLICATOR FORCEPS
K
95
1051
RITE-BITE BIOPSY FORCEPS
K
95
0786
OLYMPUS BIOPSY FORCEPS MODEL FB-44
K
95
0636
OLYMPUS DISPOSABLE BIOPSY FORCEPS
K
93
1442
11274 AB FLEXIBLE PEDIATRIC BRONCHOSCOPE
K
94
4976
BRONCHOSCOPE,NON-RIGID
K
94
4649
MILL-ROSE HARRELL BRONCHIAL BRUSH
K
94
4650
WANG BRONCHIAL NEEDLE BRUSH
K
94
3700
KARL STORZ BRONCHOSCOPE ACCESSORIES
K
94
2388
TAS-(VARIOUS) ULTRATHIN FLEXIBLE ENDOSCOPE
K
94
1264
RICHARD ROD LENS LARYNGOSCOPE
K
94
1161
FLEXIBLE GRASPING FORCEPS
K
94
0521
MILL-ROSE PROTECTED TRANSLARYNGOSCOPIC CATHETER
K
94
1158
FLEXIBLE BIOPSY CUP FORCEPS
K
93
4920
VB-1830/VB-1530, VIDEO BRONCHOSCOPE
K
93
3433
MODIFIED BRONCHOSCOPE AND ACCESSORIES
K
93
1154
EVIS 200 SYSTEM
K
92
2204
MILL-ROSE PULMONARY FORCEPS
K
92
6430
CANNULATED BIOPSY FORCEPS
K
92
3847
DISPOSABLE BRONCHOSCOPE BIOPSY FORCEPS
K
92
2937
FLEXIBLE FIBER OPTIC ENDOSCOPE
K
92
1393
IMAGICA MICRO-ENDOSCOPE
K
91
5816
BITE BLOCK/MOUTHPIECE FOR ENDOSCOPY
K
92
0025
OLYMPUS DISPOSABLE SUCTION VALVE
K
91
4181
WANG/MILL-ROSE TRANSBRONCHIAL ASPIRATION NEEDLE
K
91
0536
PROTECTED BRONCHOALVEOLAR LAVAGE BALLOON CATHETER
K
91
1922
BRONCHOSCOPE ACCESSORY, NSN 6515-00-315-2200
K
91
1412
OLYMPUS DISPOSABLE BIOPSY VALVE
K
91
0423
BRONCHOSCOPE BF-N20
K
89
5948
PORT-O-SCOPE(TM)
K
89
6146
BIOPSY FORCEPS, (NON-RIGID)
K
89
3006
EXMOOR BITE BUFFER
K
89
5415
BIOPSY FORCEPS
K
89
2687
CANNULATED BIOPSY FORCEPS
K
87
0063
CO2 LASER BRONCHOSCOPE SET
K
86
2835
CO2 FIBEROPTIC DELIVERY SYSTEM/BRONCHOSCOPIC USE
K
85
4414
DUMON/HARRELL
K
85
4581
MACHIDA SEMI-RIGID BRONCHOSCOPE FBS-6R-50
K
84
4834
MACHIDA FLEXIBLE NASOPHARYNGO-LARYNGOSCOPE FNS-1
K
83
3483
ENDOSCOPIC COUPLER
K
83
2492
BRONCHO FIBERSCOPE FB-19C
K
83
2449
LARYNGOTELESCOPE CURVED MLC-1
K
83
2010
BRONCHO-FIBERSCOPE
K
83
1240
LASER BRONCHOSCOPE
K
82
2844
PENTAX BRONCHOFIBERSCOPE #FB-19E
K
82
2257
VARIOUS TYPES OF LIGHT SOURCE HANDLES
K
82
2180
RIGID FIBEROPTIC ENDOSCOPES
K
82
2136
LASER BRONCHOSCOPE
K
81
1218
ACMI ASPIRATOR KIT #8808
K
81
1059
PENTAX BRONCHOFIBERSCOPE #FB-15A
K
81
1181
MODEL FBS-1, FLEXIBLE BRONCHOSCOPE
K
79
2342
PENTAX BROCHOFIBERSCOPE MODEL FB-17D,
K
79
2267
PENTEX BRONCHOFIBERSCOPE MODEL FB-17A
K
77
0500
3 PORT LUER
K
76
0171
FIBERBRONCHOSCOPE (PENTAX FB-17A)
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
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
/
EOQ
/
K213635
View Source
Vathin Video Bronchoscope System
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K213635
510(k) Type
Traditional
Applicant
Hunan Vathin Medical Instrument Co., Ltd.
Country
China
FDA Decision
Substantially Equivalent
Decision Date
2/28/2022
Days to Decision
103 days
Submission Type
Statement