Tactra Penile Prosthesis, 9.5 mm Device, Tactra Penile Prosthesis, 11 mm Device, Tactra Penile Prosthesis, 13 mm Device
FDA 510(k) clearance K183619 · decided 2019-04-16
Clearance details
- K-number
- K183619
- Device name
- Tactra Penile Prosthesis, 9.5 mm Device, Tactra Penile Prosthesis, 11 mm Device, Tactra Penile Prosthesis, 13 mm Device
- Applicant
- Boston Scientific Corporation
- Decision
- Substantially Equivalent
- Date received
- 2018-12-26
- Decision date
- 2019-04-16
- Days to decision
- 111 days
- Clearance type
- Traditional
- Product code
- FAE
- Device class
- 2
- Regulation number
- 876.3630
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Minnetonka, MN, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Rigi10 Malleable Penile Prosthesis (K181673) | Rigicon, Inc. | 2019-04-15 |
| AMS SPECTRA CONCEALABLE PENILE PROSTHESIS (K090663) | American Medical Systems, Inc. | 2009-04-09 |
| AMS SPECTRA CONCEALABLE PENILE PROSTHESIS (K082006) | American Medical Systems, Inc. | 2008-10-20 |
| MENTOR GENESIS PENILE PROSTHESIS (K040959) | Mentor Corp. | 2004-10-29 |
| AMS AMBICOR PENILE PROSTHESIS (K963328) | American Medical Systems, Inc. | 1996-12-04 |
| DUNA II PENILE PROSTHESIS (K953640) | Dacomed Corp. | 1995-10-27 |
| AMS 650 MALLERABLE PENIEL PROSTHESIS (K951716) | American Medical Systems, Inc. | 1995-07-06 |
| DURA II PENILE PROSTHESIS (K920420) | Dacomed Corp. | 1992-04-16 |
| AMS MALLEABLE 600 AND 600M PENILE PROSTHESIS (K912935) | American Medical Systems, Inc. | 1992-03-18 |
| MODIFIED DURAPHASE(TM) IMPLANTED PENILE PROSTHESIS (K912344) | Dacomed Corp. | 1991-10-11 |
| AMS 700 ULTREX(TM) PRECONNECTED PENILE PROSTHESIS (K910214) | American Medical Corp. | 1991-04-25 |
| MINNOW PENILE IMPLANT PROTECTOR (K904262) | Ruja-Med Medical Marketing | 1990-12-13 |
Recalls involving this device
No recalls on record reference this clearance.
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