510(k) K864040
- Device
- BARD ESKA JONAS SILICONE-SILVER PENILE PROSTHESIS
- Applicant
- C.R. BARD, INC.
- 510(k) number
- K864040
- Product code
- FAE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1986-10-24
- Date received
- 1986-10-16
- Regulation
- 876.3630
- Classification name
- Prosthesis, Penile
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- CATHERINE V BEATH
- Address
- 111 Spring St. Murray Hill NJ US 07974 07974
FDA Registration Numbers#
- 2125050
- 1000121056
- 3010273872
- 2183744
- 3013960851
- 3013987875
- 9681260
- 9616693
- 2124215
- 3005099803
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code FAE #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K183619 | Tactra Penile Prosthesis, 9.5 mm Device, Tactra Penile Prosthesis, 11 mm Device, Tactra Penile Prosthesis, 13 mm Device | Boston Scientific Corporation | 2019-04-16 |
| K181673 | Rigi10 Malleable Penile Prosthesis | Rigicon, Inc. | 2019-04-15 |
| K090663 | AMS SPECTRA CONCEALABLE PENILE PROSTHESIS | American Medical Systems, Inc. | 2009-04-09 |
| K082006 | AMS SPECTRA CONCEALABLE PENILE PROSTHESIS | American Medical Systems, Inc. | 2008-10-20 |
| K040959 | MENTOR GENESIS PENILE PROSTHESIS | Mentor Corp. | 2004-10-29 |
| K963328 | AMS AMBICOR PENILE PROSTHESIS | American Medical Systems, Inc. | 1996-12-04 |
| K953640 | DUNA II PENILE PROSTHESIS | Dacomed Corp. | 1995-10-27 |
| K951716 | AMS 650 MALLERABLE PENIEL PROSTHESIS | American Medical Systems, Inc. | 1995-07-06 |
| K920420 | DURA II PENILE PROSTHESIS | Dacomed Corp. | 1992-04-16 |
| K912935 | AMS MALLEABLE 600 AND 600M PENILE PROSTHESIS | American Medical Systems, Inc. | 1992-03-18 |
| K912344 | MODIFIED DURAPHASE(TM) IMPLANTED PENILE PROSTHESIS | Dacomed Corp. | 1991-10-11 |
| K910214 | AMS 700 ULTREX(TM) PRECONNECTED PENILE PROSTHESIS | American Medical Corp. | 1991-04-25 |
| K904262 | MINNOW PENILE IMPLANT PROTECTOR | Ruja-Med Medical Marketing | 1990-12-13 |
| K900371 | MENTOR MODIFIED MALLEABLE PENILE PROSTHESES | Mentor Corp. | 1990-11-02 |
| K901482 | 700 ULTREX PENILE PROSTHESIS 12MM DIAMETER | American Medical Systems, Inc. | 1990-06-27 |
Legacy Summary#
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FDA Review#
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