FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Tactra Penile Prosthesis, 9.5 mm Device, Tactra Penile Prosthesis, 11 mm Device, Tactra Penile Prosthesis, 13 mm Device
K Number: K183619
·
Decision Apr 16, 2019
Classifications
1
FEI Numbers
10
Registration Numbers
10
Same Product Code
31
Applicant Total
231
Review Days
111
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Basic Information
- Device Name
- Tactra Penile Prosthesis, 9.5 mm Device, Tactra Penile Prosthesis, 11 mm Device, Tactra Penile Prosthesis, 13 mm Device
- K Number
- K183619
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.3630
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Boston Scientific Corporation
- Date Received
- December 26, 2018
- Decision Date
- April 16, 2019
- Product Code
- FAE
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| FAE | Prosthesis, Penile | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FAE), ordered by most recent decision date.
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AMS SPECTRA CONCEALABLE PENILE PROSTHESIS
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MENTOR GENESIS PENILE PROSTHESIS
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AMS AMBICOR PENILE PROSTHESIS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
DUNA II PENILE PROSTHESIS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
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