Anesthesiology
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- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart D—Prosthetic DevicesCFR Sub-Part
- Subpart E—Neurological Surgical DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- EQLLaryngostroboscope1Product Code
- EOQBronchoscope (Flexible Or Rigid)2Product Code
- EOXEsophagoscope (Flexible Or Rigid)2Product Code
- BSTCurette, Biopsy, Bronchoscope (Non-Rigid)2Product Code
- BTGBrush, Biopsy, Bronchoscope (Non-Rigid)2Product Code
- BWHForceps, Biopsy, Bronchoscope (Non-Rigid)2Product Code
- EMXBalloon, Epistaxis1Product Code
- ENWCatheter, Nasopharyngeal1Product Code
- ENZTelescope, Laryngeal-Bronchial2Product Code
- EOBNasopharyngoscope (Flexible Or Rigid)2Product Code
- EQHSource, Carrier, Fiberoptic Light1Product Code
- EQJBur, Ear, Nose And Throat1Product Code
- EQNLaryngoscope, Nasopharyngoscope2Product Code
- ERAOtoscope1Product Code
- ERLDrill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece2Product Code
- EWGLaser, Ent Microsurgical Carbon-Dioxide2Product Code
- EWQSaw, Surgical, Ent (Electric Or Pneumatic)1Product Code
- EWYMediastinoscope, Surgical2Product Code
- JEIClaw, Foreign Body, Bronchoscope (Non-Rigid)2Product Code
- JEJTubing, Instrumentation, Bronchoscope (Brush Sheath A/O Aspirating)2Product Code
- JEKForceps, Biopsy, Bronchoscope (Rigid)2Product Code
- JELCurette, Biopsy, Bronchoscope (Rigid)2Product Code
- JYEChisel, Middle-Ear1Product Code
- JYFClamp, Ossicle Holding1Product Code
- JYGCurette, Ear1Product Code
- JYHExcavator, Ear1Product Code
- JYIGauge, Mastoid1Product Code
- JYJGauge, Measuring1Product Code
- JYLHook, Microsurgical Ear1Product Code
- JYMInserter, Myringotomy Tube1Product Code
- JYNInserter, Sacculotomy Tack1Product Code
- JYOKnife, Ear1Product Code
- JYPKnife, Myringotomy1Product Code
- JYQLoop, Wire1Product Code
- JYRNipper, Malleus1Product Code
- JYSPerforator, Ear-Lobe1Product Code
- JYTPick, Microsurgical Ear1Product Code
- JYWPress, Vein1Product Code
- JYXPunch, Attic1Product Code
- JYYRasp, Ear1Product Code
- JYZRod, Measuring Ear1Product Code
- JZARongeur, Mastoid1Product Code
- JZBScissors, Ear1Product Code
- JZCSearcher, Mastoid1Product Code
- JZDSnare, Ear1Product Code
- JZESpoon, Ear1Product Code
- JZFTube, Ear Suction1Product Code
- JZYKnife, Laryngeal1Product Code
- JZZSaw, Laryngeal1Product Code
- KAASet, Laryngeal Injection1Product Code
- KABTrocar, Laryngeal1Product Code
- KACTube, Laryngectomy1Product Code
- KADElevator, Ent1Product Code
- KAEForceps, Ent1Product Code
- KAHMicrorule, Ent1Product Code
- KAIMirror, Ent1Product Code
- KAJMobilizer, Ent1Product Code
- KAKProbe, Ent1Product Code
- KALRetractor, Ent1Product Code
- KAOCurette, Ethmoid1Product Code
- KAPCurette, Nasal1Product Code
- KAQGouge, Nasal, Ent1Product Code
- KARIrrigator, Sinus1Product Code
- KASKnife, Nasal1Product Code
- KATPerforator, Antrum1Product Code
- KAWPunch, Antrum1Product Code
- KAXPunch, Ethmoid1Product Code
- KAYPunch, Nasal1Product Code
- KAZRasp, Frontal-Sinus1Product Code
- KBARasp, Nasal1Product Code
- KBBRongeur, Nasal1Product Code
- KBCSaw, Nasal1Product Code
- KBDScissors, Nasal1Product Code
- KBESnare, Nasal1Product Code
- KBFTrephine, Sinus1Product Code
- KBGTrocar, Sinus1Product Code
- KBHAdenotome1Product Code
- KBIBougie, Eustachian1Product Code
- KBJCurette, Adenoid1Product Code
- KBKCurette, Salpingeal1Product Code
- KBLDepressor, Metal Tongue, Surgical1Product Code
- KBMDissector, Tonsil1Product Code
- KBNGag, Mouth1Product Code
- KBOGuillotine, Tonsil1Product Code
- KBPHook, Tonsil Suturing1Product Code
- KBQKnife, Tonsil1Product Code
- KBRNeedle, Tonsil Suturing1Product Code
- KBSPunch, Adenoid1Product Code
- KBTPunch, Tonsil1Product Code
- KBWScrew, Oral1Product Code
- KBXScrew, Tonsil1Product Code
- KBYSet, Filliform, Eustachian1Product Code
- KBZSnare, Tonsil1Product Code
- KCATonsillectome1Product Code
- KCBTube, Tonsil Suction1Product Code
- KCCBistoury, Tracheal1Product Code
- KCDBougie, Esophageal, Ent1Product Code
- KCFDilator, Esophageal, Ent1Product Code
- KCGDilator, Tracheal1Product Code
- KCHHook, Tracheal1Product Code
- KCITrocar, Tracheal1Product Code
- KTETrocar, Ent1Product Code
- KTFPunch, Ent1Product Code
- KTGKnife, Ent1Product Code
- KTIBronchoscope Accessory2Product Code
- KTRTube, Aspirating, Bronchoscope, Rigid2Product Code
- LJWTracheotome1Product Code
- LMSLaser, Microsurgical Argon, For Uses Other Than Otology, Including Laryngology & General Use In Otolaryngology2Product Code
- LRCInstrument, Ent Manual Surgical1Product Code
- LXRLaser, Microsurgical Argon, For Use In Otology2Product Code
- LYASplint, Intranasal Septal1Product Code
- MMOTray, Surgical, Ent1Product Code
- MQWTransilluminator, Fiber Optic1Product Code
- MXPBone Particle Collector1Product Code
- NLBTrocar, Tracheal, Laryngeal, Sinus, Reprocessed1Product Code
- NLEForceps, Biopsy, Bronchoscope (Non-Rigid), Reprocessed2Product Code
- NLYMicrodebrider, Ent, High Speed, Single Use, Reprocessed1Product Code
- NLZBur, Ent, Diamond Coated, Single Use, Reprocessed1Product Code
- OGREar, Nose, And Throat Surgical Tray1Product Code
- OGUPierced Ear/Entry Cleaning Tray1Product Code
- PNZEustachian Tube Balloon Dilation Device2Product Code
- QGKBalloon, Nasal Airway1Product Code
- QJLSplint, Intranasal Septal, Cber Led1Product Code
- QNWReprocessed Bronchoscope2Product Code
- QQHPowered Insertion System For A Cochlear Implant Electrode Array2Product Code
- OLLSeptal Stapler/Absorbable Staples2Product Code
- SBSLaryngeal Injection Set With Led Light1Product Code
- Subpart F—General Hospital and Personal Use Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- Subpart G—General Hospital and Personal Use Miscellaneous DevicesCFR Sub-Part
- Subpart G—Miscellaneous DevicesCFR Sub-Part
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Laryngeal Injection Set With Led Light
- Page Type
- Product Code
- Definition
- A light guided laryngeal injection set is an ear, nose, and throat manual surgical instrument and is one of a variety of devices intended for use in surgical procedures to examine or treat the bronchus, esophagus, trachea, larynx, pharynx, nasal and paranasal sinus, or ear. This generic type of device includes the esophageal dilator; tracheal bistour (a long, narrow surgical knife); tracheal dilator; tracheal hook; laryngeal injection set; laryngeal knife; laryngeal saw; laryngeal trocar; laryngectomy tube; adenoid curette; adenotome; metal tongue depressor; mouth gag; oral screw; salpingeal curette; tonsillectome; tonsil guillotine; tonsil screw; tonsil snare; tonsil suction tube; tonsil suturing hook; antom reforator; ethmoid curette; frontal sinus-rasp; nasal curette; nasal rasp; nasal rongeur; nasal saw; nasal scissors; nasal snare; sinus irrigator; sinus trephine; ear curette; ear excavator; ear rasp; ear scissor, ear snare; ear spoon; ear suction tube; malleous ripper; mastoid gauge; microsurgical ear chisel; myringotomy tube inserter; ossici holding clamp; sacculotomy tack inserter; vein press; wire ear loop; microrule; mirror; mobilizer; ear, nose, and throat punch; ear, nose and throat knife; and ear, nose, and throat trocar
- Physical State
- Laryngeal injection set with light guide consists of a light-guided needle used for injection laryngoplasty and a light generator delivers the light energy to the needle tip by generating LED light from an AC-powered light source. The light transmitted from the LED generator is emitted from the tip of fiber optics embedded within the needle tip . Laryngeal injection set with light guide is used for injection laryngoplasty procedures to indicate the injection site with visible light. This system does not contain or deliver drugs.
- Technical Method
- Laryngeal injection set with light guide consists of a light-guided needle used for injection laryngoplasty and a light generator delivers the light energy to the needle tip by generating LED light from an AC-powered light source. The light transmitted from the LED generator is emitted from the tip of fiber optics embedded within the needle tip . Laryngeal injection set with light guide is used for injection laryngoplasty procedures to indicate the injection site with visible light. This system does not contain or deliver drugs.
- Target Area
- Laryngeal injection set with light guide is used for injection laryngoplasty to address glottic incompetence to indicate the injection site with visible light
- Regulation Medical Specialty
- Ear, Nose, Throat
- Review Panel
- Ear, Nose, Throat
- Submission Type
- 510(K) Exempt
- Device Classification
- Class 1
- Regulation Number
- 874.4420
- GMP Exempt?
- No
- Summary Malfunction Reporting
- Ineligible
- Implanted Device
- No
- Life-Sustain/Support Device
- No
- Third Party Review
- Not Third Party Eligible
- MAUDE Alerts
- View and Sign Up For MAUDE Alerts
CFR § 874.4420 Ear, nose, and throat manual surgical instrument
§ 874.4420 Ear, nose, and throat manual surgical instrument.
(a) Identification. An ear, nose, and throat manual surgical instrument is one of a variety of devices intended for use in surgical procedures to examine or treat the bronchus, esophagus, trachea, larynx, pharynx, nasal and paranasal sinus, or ear. This generic type of device includes the esophageal dilator; tracheal bistour (a long, narrow surgical knife); tracheal dilator; tracheal hook; laryngeal injection set; laryngeal knife; laryngeal saw; laryngeal trocar; laryngectomy tube; adenoid curette; adenotome; metal tongue depressor; mouth gag; oral screw; salpingeal curette; tonsillectome; tonsil guillotine; tonsil screw; tonsil snare; tonsil suction tube; tonsil suturing hook; antom reforator; ethmoid curette; frontal sinus-rasp; nasal curette; nasal rasp; nasal rongeur; nasal saw; nasal scissors; nasal snare; sinus irrigator; sinus trephine; ear curette; ear excavator; ear rasp; ear scissor, ear snare; ear spoon; ear suction tube; malleous ripper; mastoid gauge; microsurgical ear chisel; myringotomy tube inserter; ossici holding clamp; sacculotomy tack inserter; vein press; wire ear loop; microrule; mirror; mobilizer; ear, nose, and throat punch; ear, nose and throat knife; and ear, nose, and throat trocar.
(b) Classification Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 874.9.
[51 FR 40389, Nov. 9, 1986, as amended at 52 FR 32111, Aug. 25, 1987; 65 FR 2316, Jan. 14, 2000; 72 FR 17400, Apr. 9, 2007]