Virilis Penile Prosthesis
FDA 510(k) K983015 · Specialty Surgical Products, Inc.
510(k) numberK983015
Submission
- Device name
- Virilis Penile Prosthesis
- Applicant
- Specialty Surgical Products, Inc.
Hamilton, MT, US - Received
- August 28, 1998
- Decision date
- February 5, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- FTQ – Prosthesis, Penis, Rigid Rod
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.3630
- Specialty
- Gastroenterology, Urology
- Implant
- Yes
Other 510(k)s with product code FTQ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K830667 | Silicone-Silver Penile Prosthesis-EskFTQ · Traditional | Dacomed Corp. | 10/20/1983SE |
More from Dacomed Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K140383 | ALLOX2 Tissue ExpandersLCJ · Traditional | 10/28/2014SE |
| K070303 | Silicone Tissue ExpanderLCJ · Traditional | 06/22/2007SE |
| K984106 | Mammary Sizer, Mammary Prothesis SizerMRD · Traditional | 02/12/1999SE |
| K982258 | Mammary SizerMRD · Traditional | 09/08/1998SE |
| K982065 | Sterile Silicone External Wound CoverMIB · Traditional | 08/12/1998SE |
| K982067 | Magnetic Port Silicone Tissue ExpanderLCJ · Traditional | 07/13/1998SE |
| K974653 | Silicone Elastomer SheetingMIB · Traditional | 03/13/1998SE |
| K974654 | Silicone BlocksMIB · Traditional | 02/24/1998SE |
| K974209 | Silicone Tissue/Inflatable Tissue ExpanderLCJ · Traditional | 02/06/1998SE |
| K973656 | Disposable Silicone Epistaxis CatheterEMX · Traditional | 11/18/1997SE |
Questions and answers
When was Virilis Penile Prosthesis cleared by the FDA?
Virilis Penile Prosthesis (K983015) received a 510(k) decision of Substantially Equivalent on February 5, 1999, 161 days after the submission was received.
What is the product code of K983015?
The FDA product code is FTQ – Prosthesis, Penis, Rigid Rod, a Class II (moderate risk) device regulated under 21 CFR 876.3630.