FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SILICONE-SILVER PENILE PROSTHESIS-ESK
K Number: K830667
·
Decision Oct 20, 1983
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
1
Applicant Total
20
Review Days
230
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- SILICONE-SILVER PENILE PROSTHESIS-ESK
- K Number
- K830667
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.3630
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Dacomed Corp.
- Date Received
- March 4, 1983
- Decision Date
- October 20, 1983
- Product Code
- FTQ
- 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 |
|---|---|---|---|
| FTQ | Prosthesis, Penis, Rigid Rod | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FTQ), ordered by most recent decision date.
View allOther Clearances by Dacomed Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K953640 | DUNA II PENILE PROSTHESIS | Oct 27, 1995 | Substantially Equivalent |
| K941781 | RIGISCAN PLUS RIGIDITY ASSESSMENT SYSTEM | Aug 25, 1994 | Substantially Equivalent |
| K920409 | DACOMED BATTERY OPERATED VACUUM ERECTION DEVICE | May 11, 1992 | Substantially Equivalent |
| K920420 | DURA II PENILE PROSTHESIS | Apr 16, 1992 | Substantially Equivalent |
| K912344 | MODIFIED DURAPHASE(TM) IMPLANTED PENILE PROSTHESIS | Oct 11, 1991 | Substantially Equivalent |
| K900774 | DACOMED NEGATIVE PRESSURE ERECTION DEVICE | May 4, 1990 | Substantially Equivalent |
| K885323 | DACOMED EXTERNAL MALE CONTINENCE DEVICE | Feb 8, 1989 | Substantially Equivalent |
| K880391 | DACOMED CYSTOMETER | Apr 27, 1988 | Substantially Equivalent |
| K871653 | DURAPHASE PENILE PROSTHESIS | Sep 18, 1987 | Substantially Equivalent |
| K870320 | DACOMED PENILE PROSTHESIS SIZER | Mar 17, 1987 | Substantially Equivalent |