Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- MiscellaneousMiscellaneous
- 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
- K230258BB 8 Sinus Dilation Kit1Cleared 510(K)
- K212774VenSure LightGuide1Cleared 510(K)
- K201398SINUSPRIME Dilation System1Cleared 510(K)
- K201115Next Generation Balloon Dilation System1Cleared 510(K)
- K201472VenSure Balloon Device, VenSure Nav Balloon Device1Cleared 510(K)
- K181546Dillard Nasal Balloon Catheter1Cleared 510(K)
- K190525RELIEVA ULTIRRA Sinus Balloon Catheter1Cleared 510(K)
- K181838Sinusway Dilation System1Cleared 510(K)
- K172737MESIRE - Balloon Sinus Dilatation System1Cleared 510(K)
- K171687Relieva SpinPlus Nav Balloon Sinuplasty System1Cleared 510(K)
- K161698Relieva UltirraNav Sinus Balloon Catheter1Cleared 510(K)
- K160770Vent-Os Sinus Dilation family1Cleared 510(K)
- K153341Relieva Scout Multi-Sinus Dilation System1Cleared 510(K)
- K152121NuVent EM Sinus Dilation System1Cleared 510(K)
- K152435PassAssist LED Light Fiber1Cleared 510(K)
- K152434XprESS Multi-Sinus Dilation System1Cleared 510(K)
- K143738DSS Sinusplasty Balloon Catheter1Cleared 510(K)
- K143541Relieva SpinPlus Balloon Sinuplasty System1Cleared 510(K)
- K150172ACCLARENT SE Inflation Device1Cleared 510(K)
- K142252XprESS Multi-Sinus Dilation Tool1Cleared 510(K)
- K141916PATHASSIST LED LIGHT FIBER1Cleared 510(K)
- K140160RELIEVA SCOUT SINUS DILATION SYSTEM1Cleared 510(K)
- K133563PATHASSIST LIGHT SEEKER1Cleared 510(K)
- K130736BLOM-SINGER ADJUSTABLE BI-FIANGED FISTULA PROSTHESIS1Cleared 510(K)
- K133016VENT-OS SINUS DILATION SYSTEM1Cleared 510(K)
- K132297EM SINUS DILATION SYSTEM1Cleared 510(K)
- K132440XPRESS MULTI-SINUS DILATION TOOL1Cleared 510(K)
- K131709SINUS DILATION SYSTEM WITH CANNULATED INSTRUMENT1Cleared 510(K)
- K130503PATHASSIST LED LIGHT FIBER1Cleared 510(K)
- K120280RELIEVA SEEKER BALLOON SINUPLASTY SYSTEM1Cleared 510(K)
- K121351SINUS DILATION SYSTEM1Cleared 510(K)
- K121943XPRESS MULTI-SINUS DILATION TOOL1Cleared 510(K)
- K121174XPRESS MULTI-SINUS DILATION TOOL1Cleared 510(K)
- K120962PATHASSIST LIGHT FIBER1Cleared 510(K)
- K120735PATHASSIT LIGHT SEEKER1Cleared 510(K)
- K113522PATHASSIST LIGHT SEEKER1Cleared 510(K)
- K112506XPRESS MULTI-SINUS DILATION TOOL1Cleared 510(K)
- K111875RELIEVA SPIN SINUS DILATION SYSTEM1Cleared 510(K)
- K111763PATHASSIST LIGHT FIBER1Cleared 510(K)
- K111254RELIEVA SOLO ELITE SINUS BALLOON CATHETER1Cleared 510(K)
- K110739ENTELLUS MEDICAL SINUS GUIDEWIRE1Cleared 510(K)
- K110158ILLUMINATING SINUS SEEKER1Cleared 510(K)
- K102003XPRESS BALLOON DEVICE1Cleared 510(K)
- K093007ENTELLUS MEDICAL BALLOON DEVICE1Cleared 510(K)
- K091681FINESS SINUS TREATMENT SYSTEM (ACCESS SHEATH COMPONENT)1Cleared 510(K)
- K081542MODIFICATION TO ENTELLUS MEDICAL RS-SERIES SYSTEM1Cleared 510(K)
- K072302ENTELLUS MEDICAL RS-SERIES SYSTEM1Cleared 510(K)
- K061903RELIEVA SINUS BALLOON CATHETER1Cleared 510(K)
- K052198RELIEVA SINUS BALLOON INFLATION DEVICE1Cleared 510(K)
- K043527RELIEVA SINUS BALLOON DILATION CATHETER1Cleared 510(K)
- K990366EXMOOR SUCTION CLEARANCE KIT1Cleared 510(K)
- K970018FAST TRACT TRANSTRACHEAL PROCEDURE KIT1Cleared 510(K)
- K942745EXMOOR SINGLE USE MYRINGOTOMES1Cleared 510(K)
- K942746SUCKER ENDS (ZOELLNER)1Cleared 510(K)
- K942064DISPOSABLE NASAL RONGEUR1Cleared 510(K)
- K942063DISPOSABLE NASAL SCISSOR1Cleared 510(K)
- K942065DISPOSABLE ENT PUNCH1Cleared 510(K)
- K933770FORCEPS, ENT INSTR, ENT MANUAL SURG RETRACT/ALL TYPE1Cleared 510(K)
- K931793SYMBIOSIS ENT SURGICAL INSTRUMENTS1Cleared 510(K)
- K930292HOUSE-BELLUCCI ALLIGATOR SCISSORS1Cleared 510(K)
- K920988ATMOS MIRROR WARMER1Cleared 510(K)
- K892504'EXMOOR' SINGLE USE SUCTION TUBE1Cleared 510(K)
- K884631FLEXIBLE ENDOSCOPE 91-8200(90) AND 91-82100(135)1Cleared 510(K)
- K873044POREX OTOLOGY INSTRUMENTS1Cleared 510(K)
- K864938'EXMOOR' MOFFAT-ROBINSON BONE PATE COLLECTOR1Cleared 510(K)
- 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
- 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
BLOM-SINGER ADJUSTABLE BI-FIANGED FISTULA PROSTHESIS
- Page Type
- Cleared 510(K)
- 510(k) Number
- K130736
- 510(k) Type
- Traditional
- Applicant
- HELIX MEDICAL, LLC
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 12/17/2013
- Days to Decision
- 274 days
- Submission Type
- Summary