Silicone-Silver Penile Prosthesis-Esk
by Dacomed Corp. 510(k)
Active
510(k) K830667
Overview
The Silicone-Silver Penile Prosthesis ESK is a rigid rod prosthesis designed for penile augmentation. It is classified as a penile prosthesis under the FDA’s device classification system (21 CFR 876.3630), intended for surgical implantation to restore erectile function in patients with erectile dysfunction.
This device is supplied sterile and intended for single-use implantation by a healthcare professional. It is regulated under the FDA’s 510(k) clearance pathway (K830667) and falls under the Gastroenterology and Urology advisory committee. The prosthesis is constructed with silicone and silver components, adhering to traditional 510(k) clearance standards established in 1983.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK830667 | Date20 Oct 1983 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 5 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- FTQ
- Device Class
- Class II
- Regulation
- 21 CFR Part 876.3630
- Advisory Committee
- Gastroenterology, Urology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Dacomed Corp.
Questions
What is the Silicone-Silver Penile Prosthesis ESK used for?
The Silicone-Silver Penile Prosthesis ESK is designed for surgical implantation to restore erectile function in patients suffering from erectile dysfunction. It functions as a rigid rod prosthesis, providing mechanical support to achieve penile rigidity during sexual activity. This device is intended for use in patients who have not responded to other treatments for erectile dysfunction.
How is the Silicone-Silver Penile Prosthesis ESK supplied and prepared for use?
The prosthesis is supplied sterile, ensuring it is ready for immediate surgical use once opened. It is intended for single-use implantation by a healthcare professional, meaning it is not designed for reuse or removal after initial placement. The sterile packaging must remain unopened until the time of surgery to maintain its sterile condition.
What materials are used in the construction of this prosthesis, and why?
The Silicone-Silver Penile Prosthesis ESK is constructed using silicone and silver components. Silicone is commonly used in medical implants due to its biocompatibility, durability, and ability to mimic natural tissue. Silver is incorporated for its antimicrobial properties, which may help reduce the risk of infection post-surgery, a critical consideration for implanted devices.
Is this device reusable, or is it intended for single-use only?
This prosthesis is explicitly intended for single-use implantation. It is not designed or approved for removal and reuse. The FDA’s 510(k) clearance and regulatory classification align with single-use medical devices, ensuring patient safety and sterility standards are met for each procedure.
How should the Silicone-Silver Penile Prosthesis ESK be stored before use?
The prosthesis should be stored in its original sterile packaging, protected from physical damage, contamination, and extreme temperatures. The packaging must remain intact until the time of surgery to preserve sterility. Follow the manufacturer’s instructions for storage conditions, typically involving a clean, dry environment away from direct sunlight or moisture.