FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VIRILIS PENILE PROSTHESIS
K Number: K983015
·
Decision Feb 5, 1999
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
1
Applicant Total
12
Review Days
161
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Basic Information
- Device Name
- VIRILIS PENILE PROSTHESIS
- K Number
- K983015
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.3630
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Specialty Surgical Products, Inc.
- Date Received
- August 28, 1998
- Decision Date
- February 5, 1999
- 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 Specialty Surgical Products, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K140383 | ALLOX2 TISSUE EXPANDERS | Oct 28, 2014 | Substantially Equivalent |
| K984106 | MAMMARY SIZER, MAMMARY PROTHESIS SIZER | Feb 12, 1999 | Substantially Equivalent |
| K982258 | MAMMARY SIZER | Sep 8, 1998 | Substantially Equivalent |
| K982065 | STERILE SILICONE EXTERNAL WOUND COVER | Aug 12, 1998 | Substantially Equivalent |
| K982067 | MAGNETIC PORT SILICONE TISSUE EXPANDER | Jul 13, 1998 | Substantially Equivalent |
| K974653 | SILICONE ELASTOMER SHEETING | Mar 13, 1998 | Substantially Equivalent |
| K974654 | SILICONE BLOCKS | Feb 24, 1998 | Substantially Equivalent |
| K974209 | SILICONE TISSUE/INFLATABLE TISSUE EXPANDER | Feb 6, 1998 | Substantially Equivalent |
| K973656 | DISPOSABLE SILICONE EPISTAXIS CATHETER | Nov 18, 1997 | Substantially Equivalent |
| K973082 | VENTRAL WALL DEFECT REDUCTION SILO | Nov 4, 1997 | Substantially Equivalent |