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Miscellaneous
Miscellaneous
Subpart B—Diagnostic Devices
CFR Sub-Part
Subpart D—Prosthetic Devices
CFR Sub-Part
Subpart E—Neurological Surgical Devices
CFR Sub-Part
Subpart E—Surgical Devices
CFR Sub-Part
EQL
Laryngostroboscope
1
Product Code
EOQ
Bronchoscope (Flexible Or Rigid)
2
Product Code
EOX
Esophagoscope (Flexible Or Rigid)
2
Product Code
BST
Curette, Biopsy, Bronchoscope (Non-Rigid)
2
Product Code
BTG
Brush, Biopsy, Bronchoscope (Non-Rigid)
2
Product Code
BWH
Forceps, Biopsy, Bronchoscope (Non-Rigid)
2
Product Code
EMX
Balloon, Epistaxis
1
Product Code
ENW
Catheter, Nasopharyngeal
1
Product Code
ENZ
Telescope, Laryngeal-Bronchial
2
Product Code
EOB
Nasopharyngoscope (Flexible Or Rigid)
2
Product Code
K
23
4096
MonoStereo
2
Cleared 510(K)
K
23
2435
Rhinolaryngoscope system
2
Cleared 510(K)
K
23
2015
ATMOS Scope (507.7000.0); ATMOS Scope Pro (507.7050.0); ATMOS Scope iPrime (507.7060.0)
2
Cleared 510(K)
K
22
2587
PatCom Distal Chip Endoscope
2
Cleared 510(K)
K
23
0536
Single-use Flexible Rhinolaryngoscope; Digital Video Monitor
2
Cleared 510(K)
K
22
1660
RHINO-LARYNGOFIBERSCOPE OLYMPUS ENF TYPE-XP
2
Cleared 510(K)
K
22
1581
Single-Use Flexible Rhinolaryngoscope
2
Cleared 510(K)
K
22
0465
PENTAX Medical EPK-3000 Imaging System with Camera Head PVK-J10, PENTAX Medical ENT Imaging System with Camera Head PVK-J10
2
Cleared 510(K)
K
22
1638
Rhino-Laryngo Videoscope Olympus ENF-VH, Rhino-Laryngo Videoscope Olympus ENF-V3
2
Cleared 510(K)
K
21
4050
ENT Nasopharyngoscope and Accessories
2
Cleared 510(K)
K
22
0004
Zsquare ENT-Flex Endoscope
2
Cleared 510(K)
K
20
2727
Peregrine Endoscopy System
2
Cleared 510(K)
K
20
0609
ENTity WiFi Video Nasopharyngoscope System
2
Cleared 510(K)
K
20
0740
HD Video Rhino Laryngoscope
2
Cleared 510(K)
K
19
2305
Colibri Endoscopy System
2
Cleared 510(K)
K
19
2090
CMOS Video Rhino-Laryngoscope SSU
2
Cleared 510(K)
K
19
1102
Precision S 4K Sinuscope
2
Cleared 510(K)
K
18
3416
Rhino-Laryngo Videoscope Olympus ENF-VT3
2
Cleared 510(K)
K
19
0972
Ambu aScope 4 RhinoLaryngo Intervention
2
Cleared 510(K)
K
18
3691
PENTAX Medical ENT Video Imaging System
2
Cleared 510(K)
K
19
1080
Ambu aScope 4 RhinoLaryngo Slim
2
Cleared 510(K)
K
18
2186
CMOS Video-Rhino-Laryngoscope System
2
Cleared 510(K)
K
18
2102
RHINO-LARYNGO VIDEOSCOPE OLYMPUS ENF-VH2, RHINO-LARYNGO VIDEOSCOPE OLYMPUS ENF-V4
2
Cleared 510(K)
K
18
2846
PENTAX Medical EPK-3000 Video Imaging System
2
Cleared 510(K)
K
18
1286
Ambu aScope RLS Slim
2
Cleared 510(K)
K
18
1240
Rhino-Laryngo Fiberscope Olympus ENF-GP2
2
Cleared 510(K)
K
17
1011
PENTAX Medical VIVIDEO ENT Videoscope Solution
2
Cleared 510(K)
K
17
3855
Sharpsite AC Rigid Endsocope
2
Cleared 510(K)
K
17
2156
PENTAX Medical EPK-3000 Video Imaging System
2
Cleared 510(K)
K
17
1402
KARL STORZ Slim Nasopharyngolaryngoscope
2
Cleared 510(K)
K
17
0453
Medrobotics Flex Robotic System
2
Cleared 510(K)
K
16
1298
ShenDa Sinuscope
2
Cleared 510(K)
K
17
0285
AED Sinuscope
2
Cleared 510(K)
K
16
2151
PENTAX Medical ENT Video Imaging System
2
Cleared 510(K)
K
16
2410
TIPCAM 1S 3D System
2
Cleared 510(K)
K
16
2916
3NT endoscopy system
2
Cleared 510(K)
K
15
3701
ULYSS Multi View Sinuscope
2
Cleared 510(K)
K
15
3009
ULTRA Telescopes
2
Cleared 510(K)
K
15
2531
InstaClear Lens Cleaner
2
Cleared 510(K)
K
15
0776
Medrobotics Flex System
2
Cleared 510(K)
K
14
3673
CMOS Video Nasopharyngoscope System
2
Cleared 510(K)
K
14
2249
SCHOELLY SINUSCOPE
2
Cleared 510(K)
K
13
1323
ECLERIS SINUSCOPE
2
Cleared 510(K)
K
13
2433
ACCLARENT CYCLOPS MULTI-ANGLE ENDOSCOPE
2
Cleared 510(K)
K
13
2009
CMOS VIDEO NASOPHARYNGOSCOPE SYSTEM
2
Cleared 510(K)
K
10
3467
CMOS VIDEO RHINO-LARYNGOSCOPE SYSTEM MODEL 11101CM
2
Cleared 510(K)
K
11
0097
ACCLARENT CYCLOPS MULTI-ANGLE ENDOSCOPE
2
Cleared 510(K)
K
10
2733
VISION-SCIENCES ENT-5000 VIDEO ENT SCOPE WITH ENDOSHEATH TECHNOLOGY, VISION-SCIENCES DPU-5000/DPU-5050 VIDEO PROCESSOR
2
Cleared 510(K)
K
10
2366
FINESS ENDOSCOPE
2
Cleared 510(K)
K
10
0577
ACCLARENT CYCLOPS MULTI-ANGLE ENDOSCOPE
2
Cleared 510(K)
K
10
0125
VISION SCIENCES FLEXIBLE ENT SCOPE
2
Cleared 510(K)
K
08
3553
NASO-LARYNGO-PHARYNGOSCOPE
2
Cleared 510(K)
K
08
0740
CLEARVIEW ENDOSCOPE COVER
2
Cleared 510(K)
K
08
2667
VISIONSENSE STEREOSCOPIC VISION SYSTEM (VS SYSTEM)
2
Cleared 510(K)
K
08
2569
ENTELLUS MEDICAL FLEXIBLE ENDOSCOPE AND EYEPIECE
2
Cleared 510(K)
K
08
0622
ENTITY NASOVIEW LED NASOPHARYNGOSCOPE, MODEL 006105
2
Cleared 510(K)
K
07
2387
KARL STORZ VIDEO RHINO-LARYNGSCOPE SYSTEM, MODEL 11101 SERIES
2
Cleared 510(K)
K
07
2073
VISION-SCIENCES ENT-5000 AND ENT-5100 VIDEO ENT SCOPE WITH ENDOSHEATH SYSTEM, DPU-5000/DPU-5050 VIDEO PROCESSOR
2
Cleared 510(K)
K
07
0580
NASOPHARYNGOSCOPE, BRONCHOSCOPE
2
Cleared 510(K)
K
07
0752
KSEA MINIATURE ENDOSCOPE, MODEL 11565
2
Cleared 510(K)
K
06
3078
MICROENDOSCOPE
2
Cleared 510(K)
K
06
1663
ENDOMEDICAL TECHNOLOGIES QUIK-COVER FLEXIBLE ENDOSCOPE BARRIER SHEATH FOR OTOLARYNGOSCOPES AND BRONCHOSCOPES
2
Cleared 510(K)
K
05
2452
VISERA RHINO-LARYNGOVIDEOSCOPE OLYMPUS ENF TYPE VT
2
Cleared 510(K)
K
05
0972
VISION-SCIENCES ENT-3000 SCOPE
2
Cleared 510(K)
K
04
0984
VISION SCIENCES MODEL ENT-2000V FLEXIBLE NASOPHARYNGO-LARYNGOSCOPE
2
Cleared 510(K)
K
03
2822
ASAP SINUSCOPE 10-0036-00,10-0037-00,10-0038,10-0039-00,10-0040-00,10-0041-00,10-0042-00,10-0043-00,10-0044-00,10-0045-0
2
Cleared 510(K)
K
03
0857
MAHE PEDIATRIC NASO PHARYNGOSCOPE ITS ASSOCIATED AND ANCILLARY EQUIPMENT AND ENDOSCOPIC ACCESSORIES
2
Cleared 510(K)
K
03
1648
VISERA RHINO-LARYNGOVIDEOSCOPE OLYMPUS ENF TYPE V
2
Cleared 510(K)
K
03
1790
SLIDE-ON ENDOSHEATH SYSTEM FOR SENSORY TESTING
2
Cleared 510(K)
K
03
0572
HENKE SASS WOLF OF AMERICA NASOPHARYNGOSCOPE
2
Cleared 510(K)
K
02
3004
LFRE INDIRECT LARYNGOSCOPE
2
Cleared 510(K)
K
02
4095
MODIFICATION TO VISION SCIENCES ENDOSHEATH SYSTEM
2
Cleared 510(K)
K
01
2543
VISION SCIENCES ENDOSHEATH SYSTEM
2
Cleared 510(K)
K
02
1073
VISERA RHINLARYNGOVIDEOSCOPE OLYMPUS ENF TYPE V
2
Cleared 510(K)
K
02
0599
MTP CLEARVISION DISPOSABLE TUBING SET
2
Cleared 510(K)
K
01
3838
KSEA CLEARVISION LENS IRRIGATION SYSTEM
2
Cleared 510(K)
K
01
3591
XENF-TP RHINO-LARYNGOFIBERSCOPE, ITS ACESSORIES AND ANCILLARY EQUIPMENT
2
Cleared 510(K)
K
01
1869
XENF-DP RHINO-LARYNGOFIBERSCOPE, ITS ACCESSORIES AND ANCILLARY EQUIPMENT
2
Cleared 510(K)
K
00
3830
ENT ENDOSCOPES
2
Cleared 510(K)
K
00
2214
SINUSCOPE AND BACCESSORIES
2
Cleared 510(K)
K
00
2700
KSEA UNIMAT 12
2
Cleared 510(K)
K
99
2526
FLEXIBLE NASOPHARYNGO-LARYNGOSCOPES, FLEXIBLE BRONCHOSCOPE
2
Cleared 510(K)
K
99
1560
NASO-LARYNGO-PHARYNGOSCOPE
2
Cleared 510(K)
K
99
0354
ENDOSHEATH
2
Cleared 510(K)
K
99
0213
HYDRACLEAR PUMP CONSOLE, HYDRACLEAR POWER SUPPLLY, HYDRACLEAR FOOTSWITCH, HYDRACLEAR SHEATHS, HYDRACLEAR SET
2
Cleared 510(K)
K
98
4369
DCI ENDOSCOPE
2
Cleared 510(K)
K
98
3123
POC ENT ENDOSCOPE - SINUSCOPE
2
Cleared 510(K)
K
98
2594
ENDO-SCRUB/ENDO-SCRUB 2
2
Cleared 510(K)
K
98
1751
SINUSCOPE AND ACCESSORIES
2
Cleared 510(K)
K
98
1458
KSEA RHINO-LARYNGO-BRONCHO-FIBERSCOPE,PEDIATRIC BRONCHO-FIBERSCOPE, AND BRONCHO-FIBERSCOPE,11001RK, 11002BC & 110
2
Cleared 510(K)
K
97
2450
FLEXTIP GRASPER
2
Cleared 510(K)
K
97
1375
GREATBATCH SCIENTIFIC MR COMPATIBLE SINUSCOPE
2
Cleared 510(K)
K
97
2855
KARL STORZ CONTACT NASAL MICRO-ENDOSCOPES
2
Cleared 510(K)
K
97
1995
MEDIVISION SINOSCOPE
2
Cleared 510(K)
K
96
5233
SHARPSITE AC
2
Cleared 510(K)
K
97
0247
SMITH & NEPHEW IMAGES ARTHROSCOPE/ENT ENDOSCOPE
2
Cleared 510(K)
K
96
2116
GALILEO ENDOSCOPES
2
Cleared 510(K)
K
96
3757
IRRIGATION/SUCTION HANDLE AND SHEATH
2
Cleared 510(K)
K
96
3426
KARL STORZ CONTACT MICRO-LARYNGOSCOPES
2
Cleared 510(K)
K
96
2255
CLARUS MURPHYPEN ENDOSCOPE(2127-XXX)
2
Cleared 510(K)
K
96
2898
KSEA UNIMAT PLUS
2
Cleared 510(K)
K
96
2396
KSEA BIPOLAR GOAGULATING FORCEPS
2
Cleared 510(K)
K
95
0809
VISION-SCIENCES DISPOSABLE ENDOSHEATH FOR FLEXIBLE NASOPHARYNGO-LARYNGOSCOPES
2
Cleared 510(K)
K
96
1591
DISPOSABLE ENDOSHEATH FOR E-F100 FLEXIBLE NASOPHARYNGOSCOPE
2
Cleared 510(K)
K
96
0876
FIVE STAR BRONCHOSCOPE
2
Cleared 510(K)
K
95
5560
TREBAY SCOPE IRRIGATED CLEARING SLEEVE
2
Cleared 510(K)
K
94
2265
FLEXIBLE NASOPHARYNGO-LARYNGOSCOPE AND ENDOSHEATH
2
Cleared 510(K)
K
95
3771
OPERATING LARYNGOSCOPES & ACCESSORIES FORCEPS, PROTECTORS
2
Cleared 510(K)
K
95
4348
GLANZ CARCINOMA GAUGE, KSEA
2
Cleared 510(K)
K
95
4336
ENDO-BEND GRASPER (114.3 MM SHAFT-STERILE)
2
Cleared 510(K)
K
95
3888
TELESCOPE 4MM, 2.7MM DIAM. WIDE ANGLE 0', 30', 70', 4MM, DIAM, 30' WORK, L 14CM, AUTOCLAVABLE
2
Cleared 510(K)
K
94
0317
SINUSCOPE
2
Cleared 510(K)
K
95
1249
CITATION SINUSCOPE
2
Cleared 510(K)
K
95
1196
FNL-10P, FIBER NASOPARHYNGOSCOPE
2
Cleared 510(K)
K
95
1201
KARL STORZ NASAL,, TONSIL, EAR, LARYNGEAL SNARE
2
Cleared 510(K)
K
94
0028
ENDOSCOPE SHEATH
2
Cleared 510(K)
K
94
5081
TRANSTYMPANIC ENDOSCOPE
2
Cleared 510(K)
K
95
0603
KARL STORZ VISCOUS FLUID INJECTION SET
2
Cleared 510(K)
K
95
0334
KARL STORZ TELE-SCRUB
2
Cleared 510(K)
K
95
0338
KARL STORZ RHINO-PHARYNGO-LARYNGO-FIBERSCOPE, BIOPSY, GRASPING FORCEPS
2
Cleared 510(K)
K
94
4861
KARL STORZ MONOPOLAR COAGULATION BALL ELECTRODES, CUTTING WIRE ELECTRODES, BIPOLAR SUCTION COAGULATOR, ELECTRODE, PROBE
2
Cleared 510(K)
K
94
6011
ARGUS SINUS ENDOSCOPY INSTRUMENT SYSTEM
2
Cleared 510(K)
K
94
6148
KARL STORS KNIVES, CURETTES, HOOKS, NEEDLES
2
Cleared 510(K)
K
94
4671
VIDEO SCOPE SYSTEM (NASOPHARYNGOSCOPE {FLEXIBLE OR RIGID})
2
Cleared 510(K)
K
94
4670
JARIT RECOMMENDED SINUS INSTRUMENTS
2
Cleared 510(K)
K
94
4656
OPTUS SINUSCOPES AND ACCESSORIES
2
Cleared 510(K)
K
94
5788
KARL STORZ RIGID TELESCOPES FOR ENT ENDOSCOPIC PROCEDURES
2
Cleared 510(K)
K
94
5381
NASOPHARYNGOSCOPES, BRONCHOSCOPES, TRACHEOSCP[ES AND ESOPHAGOSCOPES, LARYNGOSCOPES, OTO-TELESCOPES
2
Cleared 510(K)
K
94
4072
OLYMPUS NASAL AND SINUS ENDOSCOPES
2
Cleared 510(K)
K
94
4797
KARL STORZ INSULATED CANNULAE, SUCTION TUBES
2
Cleared 510(K)
K
94
4298
KARL STORZ INSULATED SCISSORS
2
Cleared 510(K)
K
94
4186
SINUSCOPE
2
Cleared 510(K)
K
94
4296
KARL STORZ OPTICAL VIDEO TONGUE DEPRESSOR
2
Cleared 510(K)
K
94
3665
NASAL ENDOSCOPY & SINUSCOPY HAND INSTRUMENTS
2
Cleared 510(K)
K
94
3816
TROCARS,CANNULAE, SHEATHS
2
Cleared 510(K)
K
94
3074
FORCEPS, PUNCHES, SCISSORS
2
Cleared 510(K)
K
93
3672
XOMED-TREACE SCOPESHEATH
2
Cleared 510(K)
K
94
1565
JARIT RECOMMENDED SINUS INSTRUMENTS
2
Cleared 510(K)
K
93
6257
ULTRATHIN FLEXIBLE ENDOSCOPE TAS-211/2.3
2
Cleared 510(K)
K
93
4422
NASOPHARYNGOSCOPE
2
Cleared 510(K)
K
93
3105
XOMED-TREACE RIGID ROD LENS ENDOSCOPE
2
Cleared 510(K)
K
93
3247
PROTECTIVE SHEATH FOR FLEXIBLE NASOPHARY/LARYGNOS
2
Cleared 510(K)
K
93
2988
ACCESSORIES FOR ENDOSCOPES FOR SINUS SURGERY
2
Cleared 510(K)
K
93
0931
NASAL/PARANASAL ENDOSCOPE
2
Cleared 510(K)
K
92
5421
ENDOSHEATH
2
Cleared 510(K)
K
92
1244
DISPOSABLE PROTECTIVE SHEATH
2
Cleared 510(K)
K
92
0439
OMEGA OTO NASOPHARYNGO-LARYNGOSCOPE
2
Cleared 510(K)
K
92
1707
PENTAX NASO-PHARYNGO-LARYNGOSCOPE FNL-15P2/15RP2
2
Cleared 510(K)
K
90
2683
SCOPESCRUBBER(TM)
2
Cleared 510(K)
K
90
0176
ENT-2 FLEXIBLE NASOPHARYGNO-LARYNGOSCOPES
2
Cleared 510(K)
K
89
6297
FLEXIBLE NASOPHARYNGOSCOPE
2
Cleared 510(K)
K
89
5245
FLEXIBLE FIBER-OPTIC NASOPHARYNGOSCOPE
2
Cleared 510(K)
K
88
2744
EFFNER ILLUMINATED NASAL TRACHEOSTOMA SPECULUM
2
Cleared 510(K)
K
87
4215
ENDOSCOPES FOR SINUS SURGERY
2
Cleared 510(K)
K
86
4821
AIRWAY FIBERSCOPES, MODELS LS-9, 0L-1, 0L-2 & PL-2
2
Cleared 510(K)
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 13 December 2024 at 11:05 pm
EN
/
subpart-e—surgical-devices
/
EOB
/
K100125
View Source
VISION SCIENCES FLEXIBLE ENT SCOPE
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K100125
510(k) Type
Special
Applicant
VISION-SCIENCES, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
2/25/2010
Days to Decision
37 days
Submission Type
Summary
FDA Browser
by
Innolitics
Anesthesiology
Cardiovascular
Chemistry
Dental
Ear, Nose, Throat
Miscellaneous
Subpart B—Diagnostic Devices
Subpart D—Prosthetic Devices
Subpart E—Neurological Surgical Devices
Subpart E—Surgical Devices
EQL
Laryngostroboscope
EOQ
Bronchoscope (Flexible Or Rigid)
EOX
Esophagoscope (Flexible Or Rigid)
BST
Curette, Biopsy, Bronchoscope (Non-Rigid)
BTG
Brush, Biopsy, Bronchoscope (Non-Rigid)
BWH
Forceps, Biopsy, Bronchoscope (Non-Rigid)
EMX
Balloon, Epistaxis
ENW
Catheter, Nasopharyngeal
ENZ
Telescope, Laryngeal-Bronchial
EOB
Nasopharyngoscope (Flexible Or Rigid)
K
23
4096
MonoStereo
K
23
2435
Rhinolaryngoscope system
K
23
2015
ATMOS Scope (507.7000.0); ATMOS Scope Pro (507.7050.0); ATMOS Scope iPrime (507.7060.0)
K
22
2587
PatCom Distal Chip Endoscope
K
23
0536
Single-use Flexible Rhinolaryngoscope; Digital Video Monitor
K
22
1660
RHINO-LARYNGOFIBERSCOPE OLYMPUS ENF TYPE-XP
K
22
1581
Single-Use Flexible Rhinolaryngoscope
K
22
0465
PENTAX Medical EPK-3000 Imaging System with Camera Head PVK-J10, PENTAX Medical ENT Imaging System with Camera Head PVK-J10
K
22
1638
Rhino-Laryngo Videoscope Olympus ENF-VH, Rhino-Laryngo Videoscope Olympus ENF-V3
K
21
4050
ENT Nasopharyngoscope and Accessories
K
22
0004
Zsquare ENT-Flex Endoscope
K
20
2727
Peregrine Endoscopy System
K
20
0609
ENTity WiFi Video Nasopharyngoscope System
K
20
0740
HD Video Rhino Laryngoscope
K
19
2305
Colibri Endoscopy System
K
19
2090
CMOS Video Rhino-Laryngoscope SSU
K
19
1102
Precision S 4K Sinuscope
K
18
3416
Rhino-Laryngo Videoscope Olympus ENF-VT3
K
19
0972
Ambu aScope 4 RhinoLaryngo Intervention
K
18
3691
PENTAX Medical ENT Video Imaging System
K
19
1080
Ambu aScope 4 RhinoLaryngo Slim
K
18
2186
CMOS Video-Rhino-Laryngoscope System
K
18
2102
RHINO-LARYNGO VIDEOSCOPE OLYMPUS ENF-VH2, RHINO-LARYNGO VIDEOSCOPE OLYMPUS ENF-V4
K
18
2846
PENTAX Medical EPK-3000 Video Imaging System
K
18
1286
Ambu aScope RLS Slim
K
18
1240
Rhino-Laryngo Fiberscope Olympus ENF-GP2
K
17
1011
PENTAX Medical VIVIDEO ENT Videoscope Solution
K
17
3855
Sharpsite AC Rigid Endsocope
K
17
2156
PENTAX Medical EPK-3000 Video Imaging System
K
17
1402
KARL STORZ Slim Nasopharyngolaryngoscope
K
17
0453
Medrobotics Flex Robotic System
K
16
1298
ShenDa Sinuscope
K
17
0285
AED Sinuscope
K
16
2151
PENTAX Medical ENT Video Imaging System
K
16
2410
TIPCAM 1S 3D System
K
16
2916
3NT endoscopy system
K
15
3701
ULYSS Multi View Sinuscope
K
15
3009
ULTRA Telescopes
K
15
2531
InstaClear Lens Cleaner
K
15
0776
Medrobotics Flex System
K
14
3673
CMOS Video Nasopharyngoscope System
K
14
2249
SCHOELLY SINUSCOPE
K
13
1323
ECLERIS SINUSCOPE
K
13
2433
ACCLARENT CYCLOPS MULTI-ANGLE ENDOSCOPE
K
13
2009
CMOS VIDEO NASOPHARYNGOSCOPE SYSTEM
K
10
3467
CMOS VIDEO RHINO-LARYNGOSCOPE SYSTEM MODEL 11101CM
K
11
0097
ACCLARENT CYCLOPS MULTI-ANGLE ENDOSCOPE
K
10
2733
VISION-SCIENCES ENT-5000 VIDEO ENT SCOPE WITH ENDOSHEATH TECHNOLOGY, VISION-SCIENCES DPU-5000/DPU-5050 VIDEO PROCESSOR
K
10
2366
FINESS ENDOSCOPE
K
10
0577
ACCLARENT CYCLOPS MULTI-ANGLE ENDOSCOPE
K
10
0125
VISION SCIENCES FLEXIBLE ENT SCOPE
K
08
3553
NASO-LARYNGO-PHARYNGOSCOPE
K
08
0740
CLEARVIEW ENDOSCOPE COVER
K
08
2667
VISIONSENSE STEREOSCOPIC VISION SYSTEM (VS SYSTEM)
K
08
2569
ENTELLUS MEDICAL FLEXIBLE ENDOSCOPE AND EYEPIECE
K
08
0622
ENTITY NASOVIEW LED NASOPHARYNGOSCOPE, MODEL 006105
K
07
2387
KARL STORZ VIDEO RHINO-LARYNGSCOPE SYSTEM, MODEL 11101 SERIES
K
07
2073
VISION-SCIENCES ENT-5000 AND ENT-5100 VIDEO ENT SCOPE WITH ENDOSHEATH SYSTEM, DPU-5000/DPU-5050 VIDEO PROCESSOR
K
07
0580
NASOPHARYNGOSCOPE, BRONCHOSCOPE
K
07
0752
KSEA MINIATURE ENDOSCOPE, MODEL 11565
K
06
3078
MICROENDOSCOPE
K
06
1663
ENDOMEDICAL TECHNOLOGIES QUIK-COVER FLEXIBLE ENDOSCOPE BARRIER SHEATH FOR OTOLARYNGOSCOPES AND BRONCHOSCOPES
K
05
2452
VISERA RHINO-LARYNGOVIDEOSCOPE OLYMPUS ENF TYPE VT
K
05
0972
VISION-SCIENCES ENT-3000 SCOPE
K
04
0984
VISION SCIENCES MODEL ENT-2000V FLEXIBLE NASOPHARYNGO-LARYNGOSCOPE
K
03
2822
ASAP SINUSCOPE 10-0036-00,10-0037-00,10-0038,10-0039-00,10-0040-00,10-0041-00,10-0042-00,10-0043-00,10-0044-00,10-0045-0
K
03
0857
MAHE PEDIATRIC NASO PHARYNGOSCOPE ITS ASSOCIATED AND ANCILLARY EQUIPMENT AND ENDOSCOPIC ACCESSORIES
K
03
1648
VISERA RHINO-LARYNGOVIDEOSCOPE OLYMPUS ENF TYPE V
K
03
1790
SLIDE-ON ENDOSHEATH SYSTEM FOR SENSORY TESTING
K
03
0572
HENKE SASS WOLF OF AMERICA NASOPHARYNGOSCOPE
K
02
3004
LFRE INDIRECT LARYNGOSCOPE
K
02
4095
MODIFICATION TO VISION SCIENCES ENDOSHEATH SYSTEM
K
01
2543
VISION SCIENCES ENDOSHEATH SYSTEM
K
02
1073
VISERA RHINLARYNGOVIDEOSCOPE OLYMPUS ENF TYPE V
K
02
0599
MTP CLEARVISION DISPOSABLE TUBING SET
K
01
3838
KSEA CLEARVISION LENS IRRIGATION SYSTEM
K
01
3591
XENF-TP RHINO-LARYNGOFIBERSCOPE, ITS ACESSORIES AND ANCILLARY EQUIPMENT
K
01
1869
XENF-DP RHINO-LARYNGOFIBERSCOPE, ITS ACCESSORIES AND ANCILLARY EQUIPMENT
K
00
3830
ENT ENDOSCOPES
K
00
2214
SINUSCOPE AND BACCESSORIES
K
00
2700
KSEA UNIMAT 12
K
99
2526
FLEXIBLE NASOPHARYNGO-LARYNGOSCOPES, FLEXIBLE BRONCHOSCOPE
K
99
1560
NASO-LARYNGO-PHARYNGOSCOPE
K
99
0354
ENDOSHEATH
K
99
0213
HYDRACLEAR PUMP CONSOLE, HYDRACLEAR POWER SUPPLLY, HYDRACLEAR FOOTSWITCH, HYDRACLEAR SHEATHS, HYDRACLEAR SET
K
98
4369
DCI ENDOSCOPE
K
98
3123
POC ENT ENDOSCOPE - SINUSCOPE
K
98
2594
ENDO-SCRUB/ENDO-SCRUB 2
K
98
1751
SINUSCOPE AND ACCESSORIES
K
98
1458
KSEA RHINO-LARYNGO-BRONCHO-FIBERSCOPE,PEDIATRIC BRONCHO-FIBERSCOPE, AND BRONCHO-FIBERSCOPE,11001RK, 11002BC & 110
K
97
2450
FLEXTIP GRASPER
K
97
1375
GREATBATCH SCIENTIFIC MR COMPATIBLE SINUSCOPE
K
97
2855
KARL STORZ CONTACT NASAL MICRO-ENDOSCOPES
K
97
1995
MEDIVISION SINOSCOPE
K
96
5233
SHARPSITE AC
K
97
0247
SMITH & NEPHEW IMAGES ARTHROSCOPE/ENT ENDOSCOPE
K
96
2116
GALILEO ENDOSCOPES
K
96
3757
IRRIGATION/SUCTION HANDLE AND SHEATH
K
96
3426
KARL STORZ CONTACT MICRO-LARYNGOSCOPES
K
96
2255
CLARUS MURPHYPEN ENDOSCOPE(2127-XXX)
K
96
2898
KSEA UNIMAT PLUS
K
96
2396
KSEA BIPOLAR GOAGULATING FORCEPS
K
95
0809
VISION-SCIENCES DISPOSABLE ENDOSHEATH FOR FLEXIBLE NASOPHARYNGO-LARYNGOSCOPES
K
96
1591
DISPOSABLE ENDOSHEATH FOR E-F100 FLEXIBLE NASOPHARYNGOSCOPE
K
96
0876
FIVE STAR BRONCHOSCOPE
K
95
5560
TREBAY SCOPE IRRIGATED CLEARING SLEEVE
K
94
2265
FLEXIBLE NASOPHARYNGO-LARYNGOSCOPE AND ENDOSHEATH
K
95
3771
OPERATING LARYNGOSCOPES & ACCESSORIES FORCEPS, PROTECTORS
K
95
4348
GLANZ CARCINOMA GAUGE, KSEA
K
95
4336
ENDO-BEND GRASPER (114.3 MM SHAFT-STERILE)
K
95
3888
TELESCOPE 4MM, 2.7MM DIAM. WIDE ANGLE 0', 30', 70', 4MM, DIAM, 30' WORK, L 14CM, AUTOCLAVABLE
K
94
0317
SINUSCOPE
K
95
1249
CITATION SINUSCOPE
K
95
1196
FNL-10P, FIBER NASOPARHYNGOSCOPE
K
95
1201
KARL STORZ NASAL,, TONSIL, EAR, LARYNGEAL SNARE
K
94
0028
ENDOSCOPE SHEATH
K
94
5081
TRANSTYMPANIC ENDOSCOPE
K
95
0603
KARL STORZ VISCOUS FLUID INJECTION SET
K
95
0334
KARL STORZ TELE-SCRUB
K
95
0338
KARL STORZ RHINO-PHARYNGO-LARYNGO-FIBERSCOPE, BIOPSY, GRASPING FORCEPS
K
94
4861
KARL STORZ MONOPOLAR COAGULATION BALL ELECTRODES, CUTTING WIRE ELECTRODES, BIPOLAR SUCTION COAGULATOR, ELECTRODE, PROBE
K
94
6011
ARGUS SINUS ENDOSCOPY INSTRUMENT SYSTEM
K
94
6148
KARL STORS KNIVES, CURETTES, HOOKS, NEEDLES
K
94
4671
VIDEO SCOPE SYSTEM (NASOPHARYNGOSCOPE {FLEXIBLE OR RIGID})
K
94
4670
JARIT RECOMMENDED SINUS INSTRUMENTS
K
94
4656
OPTUS SINUSCOPES AND ACCESSORIES
K
94
5788
KARL STORZ RIGID TELESCOPES FOR ENT ENDOSCOPIC PROCEDURES
K
94
5381
NASOPHARYNGOSCOPES, BRONCHOSCOPES, TRACHEOSCP[ES AND ESOPHAGOSCOPES, LARYNGOSCOPES, OTO-TELESCOPES
K
94
4072
OLYMPUS NASAL AND SINUS ENDOSCOPES
K
94
4797
KARL STORZ INSULATED CANNULAE, SUCTION TUBES
K
94
4298
KARL STORZ INSULATED SCISSORS
K
94
4186
SINUSCOPE
K
94
4296
KARL STORZ OPTICAL VIDEO TONGUE DEPRESSOR
K
94
3665
NASAL ENDOSCOPY & SINUSCOPY HAND INSTRUMENTS
K
94
3816
TROCARS,CANNULAE, SHEATHS
K
94
3074
FORCEPS, PUNCHES, SCISSORS
K
93
3672
XOMED-TREACE SCOPESHEATH
K
94
1565
JARIT RECOMMENDED SINUS INSTRUMENTS
K
93
6257
ULTRATHIN FLEXIBLE ENDOSCOPE TAS-211/2.3
K
93
4422
NASOPHARYNGOSCOPE
K
93
3105
XOMED-TREACE RIGID ROD LENS ENDOSCOPE
K
93
3247
PROTECTIVE SHEATH FOR FLEXIBLE NASOPHARY/LARYGNOS
K
93
2988
ACCESSORIES FOR ENDOSCOPES FOR SINUS SURGERY
K
93
0931
NASAL/PARANASAL ENDOSCOPE
K
92
5421
ENDOSHEATH
K
92
1244
DISPOSABLE PROTECTIVE SHEATH
K
92
0439
OMEGA OTO NASOPHARYNGO-LARYNGOSCOPE
K
92
1707
PENTAX NASO-PHARYNGO-LARYNGOSCOPE FNL-15P2/15RP2
K
90
2683
SCOPESCRUBBER(TM)
K
90
0176
ENT-2 FLEXIBLE NASOPHARYGNO-LARYNGOSCOPES
K
89
6297
FLEXIBLE NASOPHARYNGOSCOPE
K
89
5245
FLEXIBLE FIBER-OPTIC NASOPHARYNGOSCOPE
K
88
2744
EFFNER ILLUMINATED NASAL TRACHEOSTOMA SPECULUM
K
87
4215
ENDOSCOPES FOR SINUS SURGERY
K
86
4821
AIRWAY FIBERSCOPES, MODELS LS-9, 0L-1, 0L-2 & PL-2
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
/
EOB
/
K100125
View Source
VISION SCIENCES FLEXIBLE ENT SCOPE
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K100125
510(k) Type
Special
Applicant
VISION-SCIENCES, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
2/25/2010
Days to Decision
37 days
Submission Type
Summary