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
- K243655TurbAlign1Cleared 510(K)
- K230142Epi-Stop Nasal Gel/epistaxis pack1Cleared 510(K)
- K213153SPIWay Endonasal Access Guide1Cleared 510(K)
- K202623Novapak Nasal Sinus Packing and Stent1Cleared 510(K)
- K181696ChitoZolve1Cleared 510(K)
- K180141SPIWay Endonasal Access Guide1Cleared 510(K)
- K170913Composite Removable Sinus Stent System1Cleared 510(K)
- K172179Chitogel Endoscopic Sinus Surgery Kit1Cleared 510(K)
- K153686SPIWay Endonasal Access Guide1Cleared 510(K)
- K141816HEMOPORE1Cleared 510(K)
- K141704NOVASHIELD INJECTABLE NASAL PACKING AND STENT1Cleared 510(K)
- K141423NASOPORE-FD1Cleared 510(K)
- K140992ARTHROCARE NASASTENT CMC NASAL DRESSING1Cleared 510(K)
- K132721SPIWAY ENDONASAL ACCESS GUIDE1Cleared 510(K)
- K130354MEDIENT MIDDLE TURBINATE IMPLANT; (SINGLE PACK-1 PAIR, FOUR PACK-4 PAIR)1Cleared 510(K)
- K122494POSISEP AND POSISEP X HEMOSTAT DRESSING/INTRANASAL SPLINT1Cleared 510(K)
- K113585NASAL/EPISTAXIS PACK1Cleared 510(K)
- K092401SINEXUS SINUS STENT GEN 2, MODEL 1999-251Cleared 510(K)
- K082276SYNTHEMED DEVICE1Cleared 510(K)
- K080247QUIKCLOT NOSEBLEED1Cleared 510(K)
- K070496ADVACOAT SINUS GEL AND STENT1Cleared 510(K)
- K063308ADVACOAT SINUS GEL, MODEL 9100, ADVA SINUS STENT, MODEL 92001Cleared 510(K)
- K052099NASOPORE NASAL DRESSING, MODEL NDOX-YYY/ZZ1Cleared 510(K)
- K041381MEROPACK BIORESORBABLE NASAL PACKING AND SINUS STENT1Cleared 510(K)
- K012532SEPRAGEL SINUS1Cleared 510(K)
- K011544HADGEL, 4 GRAM/SYRINGE1Cleared 510(K)
- K002131LACTOSORB ETHMOID STENT1Cleared 510(K)
- K981374POREX NOSTRIL RETAINERS1Cleared 510(K)
- K980221SILIMED NASAL RETAINER1Cleared 510(K)
- K972096BIVALVE NASAL SPLINT1Cleared 510(K)
- K972092NASAL AIRWAY SPLINT1Cleared 510(K)
- K972151DOYLE COMBO NASAL AIRWAY SPLINT1Cleared 510(K)
- K972082CUSTOM NASAL SPLINT1Cleared 510(K)
- K954449ENT PACKINGS, WICKS, WIPES, AND SPONGES1Cleared 510(K)
- K952226C-FLEX SEPTAL SPLINTS1Cleared 510(K)
- K952207NASAL SEPTAL SPLINT1Cleared 510(K)
- K945555NASAL SPLINT1Cleared 510(K)
- K935053BIVONA NASAL TURBINATE STENT1Cleared 510(K)
- K935658MEROCEL(R) TURBINATE GLOVE AND SEPTAL SPLINT1Cleared 510(K)
- K933152MEROCEL MEROSPLINT1Cleared 510(K)
- K925173BOOMERANG TURBINATE GLOVE AND SEPTAL SPLINT1Cleared 510(K)
- K921195NASAL SEPTAL SPLINT1Cleared 510(K)
- K921202TURBINATE NASAL SPLINT1Cleared 510(K)
- K901306INVOTEC BI-VALVE SPLINT1Cleared 510(K)
- K901307PASSAGE AIRWAY SPLINT1Cleared 510(K)
- 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
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview Panel
- ImmunologyReview Panel
- MicrobiologyReview Panel
- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
SYNTHEMED DEVICE
- Page Type
- Cleared 510(K)
- 510(k) Number
- K082276
- 510(k) Type
- Traditional
- Applicant
- SYNTHEMED, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 11/18/2008
- Days to Decision
- 99 days
- Submission Type
- Summary