Subpart D—Prosthetic Devices
FDA submissions for Subpart D—Prosthetic Devices in the Gastroenterology, Urology (GU) review panel, including product codes, regulations, and recent device decisions.
Section range: §§ 876.3350–876.3750
CFR Part: 876
Product Codes
| Product Code | Device Name | Regulation | Class | Devices |
|---|---|---|---|---|
| FHW | Device, Impotence, Mechanical/Hydraulic | 876.3350 | 3 | 1 |
| JCW | Prosthesis, Penis, Inflatable | 876.3350 | 3 | 1 |
| QGA | Penile Implant Surgical Accessories | 876.3500 | 1 | 0 |
| FAE | Prosthesis, Penile | 876.3630 | 2 | 32 |
| FTQ | Prosthesis, Penis, Rigid Rod | 876.3630 | 2 | 2 |
| FAF | Prosthesis, Testicular | 876.3750 | 3 | 1 |
| FTO | Prosthesis, Testicle | 876.3750 | 3 | 0 |
Recent Devices
| Record | 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 | Apr 16, 2019 |
| K181673 | Rigi10 Malleable Penile Prosthesis | Rigicon, Inc. | Apr 15, 2019 |
| K090663 | AMS SPECTRA CONCEALABLE PENILE PROSTHESIS | American Medical Systems, Inc. | Apr 9, 2009 |
| K082006 | AMS SPECTRA CONCEALABLE PENILE PROSTHESIS | American Medical Systems, Inc. | Oct 20, 2008 |
| K040959 | MENTOR GENESIS PENILE PROSTHESIS | Mentor Corp. | Oct 29, 2004 |
| P020003 | COLOPLAST SALINE-FILLED TESTICULAR PROSTHESIS | Coloplast Corp. | Jul 19, 2002 |
| P000006 | TITAN INFLATABLE PENILE PROSTHESIS | Coloplast Corp. | Jul 14, 2000 |
| K983015 | VIRILIS PENILE PROSTHESIS | Specialty Surgical Products, Inc. | Feb 5, 1999 |
| N970012 | AMS 700 SERIES PRODUCT LINE AND THE DYNAFLEX INFLATABLE PENILE PROSTHESES | Boston Scientific Corp | Nov 2, 1998 |
| K963328 | AMS AMBICOR PENILE PROSTHESIS | American Medical Systems, Inc. | Dec 4, 1996 |
| K953640 | DUNA II PENILE PROSTHESIS | Dacomed Corp. | Oct 27, 1995 |
| K951716 | AMS 650 MALLERABLE PENIEL PROSTHESIS | American Medical Systems, Inc. | Jul 6, 1995 |
| K920420 | DURA II PENILE PROSTHESIS | Dacomed Corp. | Apr 16, 1992 |
| K912935 | AMS MALLEABLE 600 AND 600M PENILE PROSTHESIS | American Medical Systems, Inc. | Mar 18, 1992 |
| K912344 | MODIFIED DURAPHASE(TM) IMPLANTED PENILE PROSTHESIS | Dacomed Corp. | Oct 11, 1991 |
| K910214 | AMS 700 ULTREX(TM) PRECONNECTED PENILE PROSTHESIS | American Medical Corp. | Apr 25, 1991 |
| K904262 | MINNOW PENILE IMPLANT PROTECTOR | Ruja-Med Medical Marketing | Dec 13, 1990 |
| K900371 | MENTOR MODIFIED MALLEABLE PENILE PROSTHESES | Mentor Corp. | Nov 2, 1990 |
| K901482 | 700 ULTREX PENILE PROSTHESIS 12MM DIAMETER | American Medical Systems, Inc. | Jun 27, 1990 |
| K896941 | AMS DYNAFLEX SELF CONTAINED PENILE PROSTHESIS | American Medical Systems, Inc. | Mar 6, 1990 |
| K890402 | MENTOR CYLINDER PROTECTOR TOOL (INFLATABLE PENILE) | Mentor Corp. | Aug 3, 1989 |
| K871653 | DURAPHASE PENILE PROSTHESIS | Dacomed Corp. | Sep 18, 1987 |
| K864040 | BARD ESKA JONAS SILICONE-SILVER PENILE PROSTHESIS | C.R. Bard, Inc. | Oct 24, 1986 |
| K860517 | MENTOR CORPORAL DILATORS | Mentor Corp. | Mar 11, 1986 |
| K850019 | OMNI PHASE PENILE PROSTHESIS | Dacomed Corp. | Apr 9, 1985 |
| K843280 | MALLEABLE PENILE PROSTHESIS | Mentor Corp. | Oct 24, 1984 |
| K834347 | FLEXI-FLATE PENILE IMPLANT | Surgitek | Apr 2, 1984 |
| K834504 | ESKA JONAS SILICON-SILVER PENILE | Dacomed Corp. | Feb 4, 1984 |
| K832043 | SURGIKEK PENILE PROSTHESIS TAIL EXTEND | Medical Engineering Corp. | Oct 20, 1983 |
| K830667 | SILICONE-SILVER PENILE PROSTHESIS-ESK | Dacomed Corp. | Oct 20, 1983 |
| K831660 | AMS MALLEABLE PENILE PROSTHESIS | American Medical Systems, Inc. | Aug 8, 1983 |
| K830917 | SURGITEK SIZER FOR PENILE PROSTHESIS | Medical Engineering Corp. | Apr 12, 1983 |
| K830048 | INFLATABLE PENILE PROSTH. - CYLINDER | American Medical Systems, Inc. | Apr 12, 1983 |
| K821628 | THE INFLATABLE PENILE PROSTHESIS | American Medical Systems, Inc. | Aug 10, 1982 |
| K820081 | ESKA JONAS SILICONE-SILVER PENILE PROST | Dacomed Corp. | Jan 25, 1982 |
| K803111 | ERECTAID | Burditt & Calkins-Siemens-Elema | Jan 23, 1981 |
| K792724 | AMS MALLEABLE OR JONAS SILICONE-SILVER | American Medical Systems, Inc. | Sep 9, 1980 |
