Part 874 Subpart E—Surgical Devices

FDA submissions for Part 874 Subpart E—Surgical Devices in the Ear, Nose, Throat (EN) review panel, including product codes and regulations.

Section range: §§ 874.4100–874.4800

CFR Part: 874

Product Codes

Product CodeDevice NameRegulationClassDevices
EMXBalloon, Epistaxis874.4100147
EQJBur, Ear, Nose And Throat874.4140118
NLYMicrodebrider, Ent, High Speed, Single Use, Reprocessed874.414011
NLZBur, Ent, Diamond Coated, Single Use, Reprocessed874.414010
ENWCatheter, Nasopharyngeal874.417512
KBIBougie, Eustachian874.417511
KBYSet, Filliform, Eustachian874.417510
PNZEustachian Tube Balloon Dilation Device874.418029
ERLDrill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece874.4250291
EQHSource, Carrier, Fiberoptic Light874.4350149
MQWTransilluminator, Fiber Optic874.435011
EWQSaw, Surgical, Ent (Electric Or Pneumatic)874.442012
JYEChisel, Middle-Ear874.442011
JYFClamp, Ossicle Holding874.442010
JYGCurette, Ear874.442017
JYHExcavator, Ear874.442010
JYIGauge, Mastoid874.442010
JYJGauge, Measuring874.442015
JYLHook, Microsurgical Ear874.442015
JYMInserter, Myringotomy Tube874.442014
JYNInserter, Sacculotomy Tack874.442010
JYOKnife, Ear874.442017
JYPKnife, Myringotomy874.442011
JYQLoop, Wire874.442012
JYRNipper, Malleus874.442012
JYSPerforator, Ear-Lobe874.442013
JYTPick, Microsurgical Ear874.442012
JYWPress, Vein874.442011
JYXPunch, Attic874.442010
JYYRasp, Ear874.442011
JYZRod, Measuring Ear874.442011
JZARongeur, Mastoid874.442011
JZBScissors, Ear874.442014
JZCSearcher, Mastoid874.442010
JZDSnare, Ear874.442012
JZESpoon, Ear874.442011
JZFTube, Ear Suction874.442015
JZYKnife, Laryngeal874.442010
JZZSaw, Laryngeal874.442010
KAASet, Laryngeal Injection874.442010
KABTrocar, Laryngeal874.442011
KACTube, Laryngectomy874.442014
KADElevator, Ent874.442015
KAEForceps, Ent874.4420114
KAHMicrorule, Ent874.442010
KAIMirror, Ent874.442019
KAJMobilizer, Ent874.442010
KAKProbe, Ent874.442011
KALRetractor, Ent874.442015
KAOCurette, Ethmoid874.442010
KAPCurette, Nasal874.442011
KAQGouge, Nasal, Ent874.442010
KARIrrigator, Sinus874.442013
KASKnife, Nasal874.442011
KATPerforator, Antrum874.442010
KAWPunch, Antrum874.442010
KAXPunch, Ethmoid874.442010
KAYPunch, Nasal874.442010
KAZRasp, Frontal-Sinus874.442010
KBARasp, Nasal874.442010
KBBRongeur, Nasal874.442010
KBCSaw, Nasal874.442014
KBDScissors, Nasal874.442013
KBESnare, Nasal874.442010
KBFTrephine, Sinus874.442011
KBGTrocar, Sinus874.442013
KBHAdenotome874.442011
KBJCurette, Adenoid874.442011
KBKCurette, Salpingeal874.442010
KBLDepressor, Metal Tongue, Surgical874.442011
KBMDissector, Tonsil874.442011
KBNGag, Mouth874.442013
KBOGuillotine, Tonsil874.442011
KBPHook, Tonsil Suturing874.442010
KBQKnife, Tonsil874.442011
KBRNeedle, Tonsil Suturing874.442010
KBSPunch, Adenoid874.442010
KBTPunch, Tonsil874.442010
KBWScrew, Oral874.442011
KBXScrew, Tonsil874.442010
KBZSnare, Tonsil874.442011
KCATonsillectome874.442011
KCBTube, Tonsil Suction874.442011
KCCBistoury, Tracheal874.442010
KCDBougie, Esophageal, Ent874.442013
KCFDilator, Esophageal, Ent874.442013
KCGDilator, Tracheal874.442011
KCHHook, Tracheal874.442010
KCITrocar, Tracheal874.442010
KTETrocar, Ent874.442011
KTFPunch, Ent874.442010
KTGKnife, Ent874.442015
LJWTracheotome874.442012
LRCInstrument, Ent Manual Surgical874.4420165
MMOTray, Surgical, Ent874.442011
NLBTrocar, Tracheal, Laryngeal, Sinus, Reprocessed874.442010
OGREar, Nose, And Throat Surgical Tray874.442010
OGUPierced Ear/Entry Cleaning Tray874.442010
QGKBalloon, Nasal Airway874.442011
SBSLaryngeal Injection Set With Led Light874.442011
QQHPowered Insertion System For A Cochlear Implant Electrode Array874.445022
QXGCooperative Powered Surgical Assist Device For Ent Surgery874.446021
LMSLaser, Microsurgical Argon, For Uses Other Than Otology, Including Laryngology & General Use In Otolaryngology874.449022
LXRLaser, Microsurgical Argon, For Use In Otology874.449020
EWGLaser, Ent Microsurgical Carbon-Dioxide874.4500224
LLOLaser, Neodymium:Yag, Pulmonary Surgery874.4500219
BSTCurette, Biopsy, Bronchoscope (Non-Rigid)874.468020
BTGBrush, Biopsy, Bronchoscope (Non-Rigid)874.468026
BWHForceps, Biopsy, Bronchoscope (Non-Rigid)874.468026
ENZTelescope, Laryngeal-Bronchial874.468023
EOQBronchoscope (Flexible Or Rigid)874.46802238
JEIClaw, Foreign Body, Bronchoscope (Non-Rigid)874.468020
JEJTubing, Instrumentation, Bronchoscope (Brush Sheath A/O Aspirating)874.468022
JEKForceps, Biopsy, Bronchoscope (Rigid)874.468023
JELCurette, Biopsy, Bronchoscope (Rigid)874.468021
KTIBronchoscope Accessory874.4680233
KTRTube, Aspirating, Bronchoscope, Rigid874.468024
NLEForceps, Biopsy, Bronchoscope (Non-Rigid), Reprocessed874.468020
QNWReprocessed Bronchoscope874.468022
EOXEsophagoscope (Flexible Or Rigid)874.4710230
EWYMediastinoscope, Surgical874.4720211
EQLLaryngostroboscope874.475018
EOBNasopharyngoscope (Flexible Or Rigid)874.47602161
EQNLaryngoscope, Nasopharyngoscope874.4760222
ERAOtoscope874.4770156
SHLEar, Nose, And Throat Image Analyzer874.477521
LYASplint, Intranasal Septal874.4780146
QJLSplint, Intranasal Septal, Cber Led874.478011
MXPBone Particle Collector874.480010
Innolitics

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