Anesthesiology
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- 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
- ETWCalibrator, Hearing Aid / Earphone And Analysis Systems2Product Code
- EWLProsthesis, Laryngeal (Taub)2Product Code
- K141380PROVOX FREEHANDS FLEXIVOICE2Cleared 510(K)
- K131947PROVOX VEGA PUNCTURE SET2Cleared 510(K)
- K092593PROVOX ACTIVALVE (SIZE 4.5MM, 6MM, 8MM, 10MM, 12.5MM)2Cleared 510(K)
- K093258BLOM-SINGER INDWELLING TEP OCCLUDER2Cleared 510(K)
- K090455PROVOX VEGA, MODEL 8130-81352Cleared 510(K)
- K082206BLOM-SINGER DUAL VALVE INDWELLING VOICE PROSTHESIS, MODELS DV-1600 SERIES, DV-2000 SERIES2Cleared 510(K)
- K043138PROVOX NID VOICE REHABILITATION SYSTEM, MODEL REF 7101 TO 71342Cleared 510(K)
- K022125PROVOX FREEHANDS HME, MODEL 77102Cleared 510(K)
- K991587BLOM-SINGER INDWELLING 2000 VOICE PROSTHESIS2Cleared 510(K)
- K974132VOICE MASTER PROSTHESIS2Cleared 510(K)
- K971244PROVOX 2 VOICE PROSTHESIS SYSTEM2Cleared 510(K)
- K945287INHEALTH BLOM-SINGER INDWELLING VALVED INSERT ACCESSORY DEVICE2Cleared 510(K)
- K945288INHEALTH BLOM-SINGER INDWELLING PLUG INSERT ACCESSORY DEVICE2Cleared 510(K)
- K940638PROVOX(TM) VOICE PROSTHESIS2Cleared 510(K)
- K932120BLOM-SINGER INDWELLING LOW PRESSURE VOICE PROSTHES2Cleared 510(K)
- K932163BLOM-SINGER VOICE PROSTHESIS FLUSHING PIPET2Cleared 510(K)
- K930105BLOM-SINGER LOW PRESSURE VOICE PROSTHESIS,P.I.D.S.2Cleared 510(K)
- K920090BLOM-SINGER TRACHEOESOPHAGEAL PUNCTURE SET2Cleared 510(K)
- K912486SINGH SPEECH SYSTEM (SERIES 'SSS')2Cleared 510(K)
- K915761BIVONA-COLORADO VOICE PROSTHESIS2Cleared 510(K)
- K904729BLOM-SINGER SHOWER GUARD2Cleared 510(K)
- K902112BLOM-SINGER(R) TRACHEOESOPHAGEAL FISTULA STENT2Cleared 510(K)
- K900518BLOM-SINGER(R) TRACHEOESOPHAGEAL PUNCTURE KIT2Cleared 510(K)
- K881011BIVONA ULTRA LOW RESISTANCE VOICE PROSTHESIS2Cleared 510(K)
- K871885ESKA-HERRMANN TRACHEOSTOMY VALVE2Cleared 510(K)
- K861088BIVONA ECONOMY DUCKBILL VOICE PROSTHESIS2Cleared 510(K)
- K854118DACOMED CORP. ESKA-HERRMAN VOICE PROSTHESIS2Cleared 510(K)
- K854112FLEXIBLE GRASPING FORCEPS2Cleared 510(K)
- K853940THE GRONINGEN VOICE PROSTHESIS2Cleared 510(K)
- K842896BLOM-SINGER LOW PRESSURE VOICE PROSTHES2Cleared 510(K)
- K832967DUCKBILL VOICE PROSTHESIS & TRACHEO2Cleared 510(K)
- K832852BLAISE-RATHAEL VOICE PROSTHESIS2Cleared 510(K)
- K823749LOW PRESSURE BLOM-SINGER VOICE PROSTHES2Cleared 510(K)
- K821568BLOW-SINGER TRACHEOSTOMA VALVE2Cleared 510(K)
- K820737PERISCOPE VOICE PROSTHESIS2Cleared 510(K)
- K812982BLOM-SINGER VOICE PROSTHESIS2Cleared 510(K)
- K812864SILASTIC VOICE PROSTHESIS2Cleared 510(K)
- K810020PANJE VOICE PROSTHESIS2Cleared 510(K)
- K800563BLOM-SINGER DUCKBILL VOICE PROSTHESIS2Cleared 510(K)
- 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
BLOM-SINGER INDWELLING LOW PRESSURE VOICE PROSTHES
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K932120
- 510(k) Type
- Traditional
- Applicant
- HELIX MEDICAL, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 4/15/1994
- Days to Decision
- 347 days
- Submission Type
- Statement