Anesthesiology
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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)
Show All 32 Submissions
- 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
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Tactra Penile Prosthesis, 9.5 mm Device, Tactra Penile Prosthesis, 11 mm Device, Tactra Penile Prosthesis, 13 mm Device
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K183619
- 510(k) Type
- Traditional
- Applicant
- Boston Scientific Corporation
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 4/16/2019
- Days to Decision
- 111 days
- Submission Type
- Summary