FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DACOMED NEGATIVE PRESSURE ERECTION DEVICE
K Number: K900774
·
Decision May 4, 1990
Classifications
1
FEI Numbers
49
Registration Numbers
49
Same Product Code
86
Applicant Total
20
Review Days
73
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Basic Information
- Device Name
- DACOMED NEGATIVE PRESSURE ERECTION DEVICE
- K Number
- K900774
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5020
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Dacomed Corp.
- Date Received
- February 20, 1990
- Decision Date
- May 4, 1990
- Product Code
- LKY
- 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 |
|---|---|---|---|
| LKY | Device, External Penile Rigidity | FDA class 2 | Gastroenterology, Urology |
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Other 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 |
| 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 |
| K854118 | DACOMED CORP. ESKA-HERRMAN VOICE PROSTHESIS | Mar 17, 1986 | Substantially Equivalent |