Anesthesiology
Review Panel
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- MiscellaneousMiscellaneous
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart B—Obstetrical and Gynecological Diagnostic DevicesCFR Sub-Part
- Subpart C—Cardiovascular Monitoring DevicesCFR Sub-Part
- Subpart C—Monitoring DevicesCFR Sub-Part
- Subpart D—Prosthetic DevicesCFR Sub-Part
- FAEProsthesis, Penile2Product Code
- K183619Tactra Penile Prosthesis, 9.5 mm Device, Tactra Penile Prosthesis, 11 mm Device, Tactra Penile Prosthesis, 13 mm Device2Cleared 510(K)
- K181673Rigi10 Malleable Penile Prosthesis2Cleared 510(K)
- K090663AMS SPECTRA CONCEALABLE PENILE PROSTHESIS2Cleared 510(K)
- K082006AMS SPECTRA CONCEALABLE PENILE PROSTHESIS2Cleared 510(K)
- K040959MENTOR GENESIS PENILE PROSTHESIS2Cleared 510(K)
- K963328AMS AMBICOR PENILE PROSTHESIS2Cleared 510(K)
- K953640DUNA II PENILE PROSTHESIS2Cleared 510(K)
- K951716AMS 650 MALLERABLE PENIEL PROSTHESIS2Cleared 510(K)
- K920420DURA II PENILE PROSTHESIS2Cleared 510(K)
- K912935AMS MALLEABLE 600 AND 600M PENILE PROSTHESIS2Cleared 510(K)
- K912344MODIFIED DURAPHASE(TM) IMPLANTED PENILE PROSTHESIS2Cleared 510(K)
- K910214AMS 700 ULTREX(TM) PRECONNECTED PENILE PROSTHESIS2Cleared 510(K)
- K904262MINNOW PENILE IMPLANT PROTECTOR2Cleared 510(K)
- K900371MENTOR MODIFIED MALLEABLE PENILE PROSTHESES2Cleared 510(K)
- K901482700 ULTREX PENILE PROSTHESIS 12MM DIAMETER2Cleared 510(K)
- K896941AMS DYNAFLEX SELF CONTAINED PENILE PROSTHESIS2Cleared 510(K)
- K890402MENTOR CYLINDER PROTECTOR TOOL (INFLATABLE PENILE)2Cleared 510(K)
- K871653DURAPHASE PENILE PROSTHESIS2Cleared 510(K)
- K864040BARD ESKA JONAS SILICONE-SILVER PENILE PROSTHESIS2Cleared 510(K)
- K860517MENTOR CORPORAL DILATORS2Cleared 510(K)
- K850019OMNI PHASE PENILE PROSTHESIS2Cleared 510(K)
- K843280MALLEABLE PENILE PROSTHESIS2Cleared 510(K)
- K834347FLEXI-FLATE PENILE IMPLANT2Cleared 510(K)
- K834504ESKA JONAS SILICON-SILVER PENILE2Cleared 510(K)
- K832043SURGIKEK PENILE PROSTHESIS TAIL EXTEND2Cleared 510(K)
- K831660AMS MALLEABLE PENILE PROSTHESIS2Cleared 510(K)
- K830917SURGITEK SIZER FOR PENILE PROSTHESIS2Cleared 510(K)
- K830048INFLATABLE PENILE PROSTH. - CYLINDER2Cleared 510(K)
- K821628THE INFLATABLE PENILE PROSTHESIS2Cleared 510(K)
- K820081ESKA JONAS SILICONE-SILVER PENILE PROST2Cleared 510(K)
- K803111ERECTAID2Cleared 510(K)
- K792724AMS MALLEABLE OR JONAS SILICONE-SILVER2Cleared 510(K)
- FAFProsthesis, Testicular3Product Code
- FHWDevice, Impotence, Mechanical/Hydraulic3Product Code
- FTOProsthesis, Testicle3Product Code
- FTQProsthesis, Penis, Rigid Rod2Product Code
- JCWProsthesis, Penis, Inflatable3Product Code
- QGAPenile Implant Surgical Accessories1Product Code
- ESWProsthesis, Esophageal2Product Code
- MQRStent, Colonic, Metallic, Expandable2Product Code
- MUMStent, Metallic, Expandable, Duodenal2Product Code
- OTMMesh, Surgical, For Stress Urinary Incontinence, Male2Product Code
- OTNMesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator2Product Code
- PAGMesh, Surgical, Non-Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator2Product Code
- PAHMesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-Sling2Product Code
- Subpart E—Obstetrical and Gynecological Surgical DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—Neurological Therapeutic DevicesCFR Sub-Part
- Subpart F—Physical Medicine Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- Subpart G—General Hospital and Personal Use Miscellaneous DevicesCFR Sub-Part
- General HospitalReview Panel
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- 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
OMNI PHASE PENILE PROSTHESIS
- Page Type
- Cleared 510(K)
- 510(k) Number
- K850019
- 510(k) Type
- Traditional
- Applicant
- DACOMED CORP.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 4/9/1985
- Days to Decision
- 96 days