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
- EPFHearing Aid, Group And Auditory Trainer2Product Code
- NEACement, Ear, Nose And Throat2Product Code
- ESDHearing Aid, Air Conduction1Product Code
- ESELarynx, Artificial (Battery-Powered)1Product Code
- ESHPolymer, Ent Synthetic-Pife, Silicon Elastomer, Polyethylene, Polyurethane2Product Code
- ESXTack, Sacculotomy (Cody Tack)2Product Code
- ESZTube, Shunt, Endolymphatic2Product Code
- ETAReplacement, Ossicular Prosthesis, Total2Product Code
- ETBProsthesis, Partial Ossicular Replacement2Product Code
- ETCMold, Middle-Ear2Product Code
- ETDTube, Tympanostomy2Product Code
- K232702Solo+ Tympanostomy Tube Device (TTD)2Cleared 510(K)
- K233658Biowy Tym Tube (TT)2Cleared 510(K)
- K232059Tympanostomy Tubes2Cleared 510(K)
- K221254Hummingbird Tympanostomy Tube System2Cleared 510(K)
- K200952Hummingbird Tympanostomy Tube System2Cleared 510(K)
- K171239TULA Tube Delivery System2Cleared 510(K)
- K151830Hummingbird Tympanostomy Tube2Cleared 510(K)
- K151067Ventilation (Tympanostomy) Tubes2Cleared 510(K)
- K142282HUMMINGBIRD(TM) TYMPANOSTOMY TUBE SYSTEM (TTS)2Cleared 510(K)
- K133921PRECEPTIS TYMPANOSTOMY TUBE INSERTER2Cleared 510(K)
- K103595ACCLARENT TYMPANOSTOMY TUBE AND TYMPANOSTOMY TUBE DELIVERY SYSTEM2Cleared 510(K)
- K082188TYMPANOSTOMY TUBE2Cleared 510(K)
- K071150TROCAR VENTILATION TUBE/WITH TROCAR TIP, TROCAR HANDLE, MODEL 1015 074, 1015 076, 1015 075, 1015 077, W/ RETENTION WIRE2Cleared 510(K)
- K071178OTOMEDICS SOFT TYMPANOSTOMY TUBE2Cleared 510(K)
- K062672GRACE MEDICAL PC COATED TYMPANOSTOMY TUBES2Cleared 510(K)
- K062385BLUE PTFE (FLUOROPLASTIC) VENTILATION TUBES2Cleared 510(K)
- K061058NEOZOLINE VENTILATION TUBES2Cleared 510(K)
- K011383MICRODOSE CATH, MODELS 90121-201, -202, -2032Cleared 510(K)
- K000801PC COATED FLUOROPLASTIC VENT TUBES2Cleared 510(K)
- K992222FLUOROPLASTIC VENTILATION TUBES2Cleared 510(K)
- K991670SILVERSTEIN MICROWICK2Cleared 510(K)
- K980828EXMOOR MYRINGOTOMY KIT2Cleared 510(K)
- K981575TYMPANOSTOMY TUBE2Cleared 510(K)
- K974008PFLEIDERER'S INTRATYMPANIC CATHETER2Cleared 510(K)
- K973740ROUND WINDOW E-CATH2Cleared 510(K)
- K974007SHAH PERMAVENT2Cleared 510(K)
- K973226TUBINGEN TYMPANIC VENTILATION TUBE, TYMPANIC VENTILATION TUBES WITH ENE/S, DIABOLO TYMPANIC VENTILATION TUBE, MINIMAL T)2Cleared 510(K)
- K972126MYRINGOTOMY TUBE2Cleared 510(K)
- K972400MYRINGOTOMY TUBE - BOBBIN WITH TAB2Cleared 510(K)
- K971943MYRINGOTOMY TUBE2Cleared 510(K)
- K971454TYMPANOSTOMY VENTILATION TUBE2Cleared 510(K)
- K971124TM MICRO-CATHETERS2Cleared 510(K)
- K965115ROUND WINDOW CATH2Cleared 510(K)
- K963727HOFFMAN H/A COATED LONG-TERM VENTILATION TUBE WITH LINER2Cleared 510(K)
- K961873ACTIVENT ANTIMICROBIAL VENTILATION TUBES2Cleared 510(K)
- K961945TYMPANOSTOMY VENTILATION TUBE2Cleared 510(K)
- K960742TYMPANOSTOMY VENTILATION TUBE2Cleared 510(K)
- K960477VENTILATION TUBES2Cleared 510(K)
- K955616MISTEN MEDICAL REUTER BOBBIN STYLE VENT TUBE2Cleared 510(K)
- K955447TYMPANOSTOMY TUBE2Cleared 510(K)
- K954795AT2 & DOYLE STYLE (C-FLEX) VENT TUBES2Cleared 510(K)
- K953802TYMPANOSTOMY TUBE2Cleared 510(K)
- K953993TYMPASNOSTOMY TUBE2Cleared 510(K)
- K941407TYMPANOSTOMY (VENTILATION) TUBE2Cleared 510(K)
- K943325TYMPANOSTOMY TUBE2Cleared 510(K)
- K943848COLLAR BUTTON VENTURI VENT TUBE2Cleared 510(K)
- K943849GROMMENT STYLE VENTURI TUBE2Cleared 510(K)
- K943847BOBBIN STYLE VENTURI VENT TUBE2Cleared 510(K)
- K943281POLYETHYLENE VENT TUBES2Cleared 510(K)
- K943190C-FLEX VENT TUBES2Cleared 510(K)
- K936275TYMPOVENT2Cleared 510(K)
- K932166SILICONE TYMPANOSTOMY TUBES2Cleared 510(K)
- K923353VENTILATION TUBES W/ HYDROGEL COATING2Cleared 510(K)
- K926462BEL-AIR VENTILATION TUBE2Cleared 510(K)
- K923887JACK'S VENT TUBES2Cleared 510(K)
- K921923TITANIUM VENTILATION TUBES2Cleared 510(K)
- K911580DONALDSON/SHEPARDS DR/COLLAR/SHAH VENT-MINI TUBES2Cleared 510(K)
- K910618SUH VENT TUBE2Cleared 510(K)
- K904597GROMMET STYLE VENTURI2Cleared 510(K)
- K904594COLLAR BUTTON STYLE VENTURI2Cleared 510(K)
- K904592BOBBIN STYLE VENTURI2Cleared 510(K)
- K903285MICRO BRIGHT VENTILATION TUBES2Cleared 510(K)
- K900267JAHN VENTILATION TUBE2Cleared 510(K)
- K895242PAPPAS TRI-FLANGE VENTILATION TUBE2Cleared 510(K)
- K883667DONALDSON VENTILATION TUBES PT. # AG/S92Cleared 510(K)
- K882689PUNCH MYRINGOTOMY SYSTEM2Cleared 510(K)
- K870877BIO-VENT REUTER BOBBIN TUBE2Cleared 510(K)
- K871035'EXMOOR' T-TUBE2Cleared 510(K)
- K870129VENTILATION TUBES WITH HYDROGEL COATING2Cleared 510(K)
- K853641GODDE T-TUBE BLUE SILICONE TYMPANOSTOMY TUBE2Cleared 510(K)
- K852387GOODE T-TUBE WHITE SILICONE TYMPANOSTOMY TUBE2Cleared 510(K)
- K833246TYMPANOSTOMY TUBES-VARIOUS2Cleared 510(K)
- K842637UNIFLOW VENT TUBE2Cleared 510(K)
- K833910TSH RIA2Cleared 510(K)
- K823910DONALDSON VENT TUBE2Cleared 510(K)
- K833909VENTRESCREEN BETA-HCG ENZYME IMMUNO2Cleared 510(K)
- K832362DONALDSON-TYPE VENT TUBE2Cleared 510(K)
- K832361CONCEPT T-TUBE2Cleared 510(K)
- K830584SOILEAU TYTAN BOBBIN VENT TUBE2Cleared 510(K)
- K823909T-TUBE VENT TUBE2Cleared 510(K)
- K830228OTOLOGICAL VENTILATION TUBES-VARIOUS2Cleared 510(K)
- K830085COLLAR BUTTON VENT TUBE2Cleared 510(K)
- K823908GROMMET VENT TUBE2Cleared 510(K)
- K823907COLLAR BUTTON VENT TUBE2Cleared 510(K)
- K822017TYMPANOSTOMY TUBES & VARIOUS TYPES2Cleared 510(K)
- K822376TYTAN REUTER BOBBIN VENT TUBE2Cleared 510(K)
- K822375ARMSTRONG V VENT TUBE2Cleared 510(K)
- K822366TYTAN GROMMET VENT TUBE, .0402Cleared 510(K)
- K820510TYMPANOSTOMY TUBES (VARIOUS MODELS2Cleared 510(K)
- K820362REUTER BOBBIN VENTILA. TUBE-TITANIUM2Cleared 510(K)
- K813616TEKNA MED MYRINGOTOMY DISPOS-OTO KIT2Cleared 510(K)
- K812459EXMOOR AURAL GROMMET AG/TI2Cleared 510(K)
- K812460VARIOUS AURAL GROMMETS2Cleared 510(K)
- K811698CARL ZEISS INN MYRINGOTOMY TUBE LINE2Cleared 510(K)
- K810705EXMOOR AURAL GROMMET AG/T42Cleared 510(K)
- K810704EXMOOR AURAL GROMMET AG/T32Cleared 510(K)
- K810703EXMOOR AURAL GROMMET AG/T22Cleared 510(K)
- K810701EXMOOR AURAL GROMMET2Cleared 510(K)
- K810702EXMOOR AURAL GROMMET AG/T2L2Cleared 510(K)
- K810706EXMOOR AURAL GROMMET AG/T52Cleared 510(K)
- K802638OTOLOGICAL VENTILATION TUBES2Cleared 510(K)
- K802587OTOLOGICAL VENTILATION TUBES2Cleared 510(K)
- K800728PAPARELL TYPE 2, BIOLITE COATED SILI-2Cleared 510(K)
- K800727GOODE T-TUBE, BIOLITE COATED SILICONE/TU2Cleared 510(K)
- K791680POPE UMBRELLA TUBE2Cleared 510(K)
- K790216VENTILATION TUBE, SHEEHY COLLAT2Cleared 510(K)
- K781257VENTILATION TUBE SILI. SHEPPARD TYPE2Cleared 510(K)
- K781260VENTILATION TUBE SILICONE PAPARELLA TYPE2Cleared 510(K)
- K781259VENTILATION TUBE TEFLON SHEPARD TYPE2Cleared 510(K)
- K781258VENTILATION TUBE. SILI. DONALDSON TYPE2Cleared 510(K)
- K780956OTOLOGICAL VENTILATION TUBES2Cleared 510(K)
- K772066PULLEN PLASTIC-PORE PLUGS2Cleared 510(K)
- K760439PLASTI-PORE BOBBIN DRAIN TUBE, OTOLOGY2Cleared 510(K)
- K760438SPOON-BOBBIN DRAIN TUBE W/ WIRE, OTOLOGY2Cleared 510(K)
- ETWCalibrator, Hearing Aid / Earphone And Analysis Systems2Product Code
- EWLProsthesis, Laryngeal (Taub)2Product Code
- FWNProsthesis, Larynx (Stents And Keels)2Product Code
- JAZProsthesis, Facial, Mandibular Implant2Product Code
- JOFPolymer, Ent Synthetic, Porous Polyethylene2Product Code
- JXSBlock, Cutting, Ent, Sterile1Product Code
- JXTCrimper, Wire, Ent, Sterile1Product Code
- JXWDie, Wire Bending, Ent, Sterile1Product Code
- JXXForceps, Wire Closure, Ent, Sterile1Product Code
- JXYJig, Piston Cutting, Ent, Sterile1Product Code
- JXZPunch, Gelfoam, Sterile1Product Code
- JYAScissors, Wire Cutting, Ent, Sterile1Product Code
- JYBVise, Ossicular Finger, Sterile1Product Code
- KHJPolymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)2Product Code
- KHLHearing Aid, Master2Product Code
- KLWMasker, Tinnitus2Product Code
- KLZTube, Shunt, Endolymphatic With Valve2Product Code
- KQLTube, Tympanostomy With Semi-Permeable Membrane2Product Code
- LBLTube, Tympanostomy, Porous Polyethylene2Product Code
- LBMPorous Polyethylene Ossicular Replacement2Product Code
- LBNReplacement, Total Ossicular, Prosthesis, Porous, Polyethylene2Product Code
- LBPReplacement, Ossicular (Stapes) Using Absorbable Gelatin Material2Product Code
- LDGKit, Earmold, Impression1Product Code
- LRBFace Plate Hearing Aid1Product Code
- LREInstrument, Prosthesis Modification For Ossicular Replacement Surgery, Sterile1Product Code
- LWFDilator, Nasal1Product Code
- LXBHearing Aid, Bone Conduction2Product Code
- LZIDevice, Assistive Listening2Product Code
- MAHHearing Aid, Bone Conduction, Implanted2Product Code
- MCKDevice, Voice Amplification2Product Code
- MIXSystem, Vocal Cord Medialization2Product Code
- NHBPolymer, Ear, Nose And Throat, Synthetic, Absorbable2Product Code
- NIXHearing Aid, Air Conduction, Transcutaneous System2Product Code
- NNNCrimper, Wire, Ent, Non-Sterile1Product Code
- NNOJig, Piston Cutting, Ent, Non-Sterile1Product Code
- NNPDie, Wire Bending, Ent, Non-Sterile1Product Code
- NNQForceps, Wire Closure, Ent, Non-Sterile1Product Code
- NNRBlock, Cutting, Ent, Non-Sterile1Product Code
- NNSInstrument, Prosthesis Modification For Ossicular Replacement Surgery, Non-Sterile1Product Code
- NNTPunch, Gelfoam, Non-Sterile1Product Code
- NNUScissors, Wire Cutting, Ent, Non-Sterile1Product Code
- NNVVise, Ossicular Finger, Non-Sterile1Product Code
- OGSMyringotomy Procedure Kit2Product Code
- OSMHearing Aid, Air Conduction With Wireless Technology2Product Code
- PFOActive Implantable Bone Conduction Hearing System2Product Code
- PLKTympanic Membrane Direct Contact Hearing Aid2Product Code
- QDDSelf-Fitting Air-Conduction Hearing Aid2Product Code
- QUFHearing Aid, Air-Conduction, Over The Counter1Product Code
- QUGHearing Aid, Air-Conduction With Wireless Technology, Over The Counter2Product Code
- QUHSelf-Fitting Air-Conduction Hearing Aid, Over The Counter2Product Code
- Subpart E—Neurological Surgical DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- 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
PAPARELL TYPE 2, BIOLITE COATED SILI-
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K800728
- 510(k) Type
- Traditional
- Applicant
- XOMED, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 4/16/1980
- Days to Decision
- 15 days