Eska Jonas Silicon-Silver Penile
by Dacomed Corp. 510(k)
Active
510(k) K834504
Overview
The Eska Jonas Silicone-Silver Penile Prosthesis is a penile implant classified as a penile prosthesis. It consists of a pair of semi-rigid rods designed to be surgically implanted within the corpora cavernosa of the penis to provide mechanical rigidity for men experiencing erectile dysfunction. Constructed from silicone and silver-infused materials, this device is intended to restore penile function through physical support rather than hydraulic or inflatable mechanisms. Its design aligns with the regulatory classification of a penile prosthesis under the FDA’s product code FAE.
This device is supplied sterile and intended for single-use implantation by a healthcare professional in an operating room setting. It is regulated under FDA 510(k) clearance (K834504) and falls under the Gastroenterology and Urology advisory committees, with a classification as a Class II medical device. The prosthesis is available in multiple sizes, as indicated by the registration numbers (e.g., 3013960851), and must be stored according to manufacturer instructions to maintain sterility and integrity prior to use. No MRI safety information is specified in the available data.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK834504 | Date4 Feb 1984 | 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- Withdrawn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
- FAE
- 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 Eska Jonas Silicone-Silver Penile Prosthesis used for?
This device is designed to restore penile function in men experiencing erectile dysfunction. It provides mechanical rigidity through a pair of semi-rigid silicone rods surgically implanted within the corpora cavernosa of the penis. Unlike hydraulic or inflatable prostheses, it relies on physical support to achieve and maintain an erection.
How is the Eska Jonas Silicone-Silver Penile Prosthesis supplied and prepared for use?
The prosthesis is supplied sterile and intended exclusively for single-use implantation by a healthcare professional in an operating room setting. It must be handled according to the manufacturer’s instructions to preserve sterility and structural integrity before use. No reprocessing or reuse is permitted.
What sizes or models are available for the Eska Jonas Silicone-Silver Penile Prosthesis?
This prosthesis comes in multiple sizes, each identified by a unique registration number. Examples include 3013960851, 3002618605, 1000121056, and others. The selection of the correct size is critical for proper function and patient comfort, so it should be determined by a clinician based on anatomical measurements.
How should the Eska Jonas Silicone-Silver Penile Prosthesis be stored before use?
The device must be stored according to the manufacturer’s instructions to maintain sterility and prevent damage. Improper storage—such as exposure to moisture, extreme temperatures, or physical stress—could compromise its integrity. Always verify the packaging remains intact and unopened until immediately before surgical use.
Is there any special handling required for the Eska Jonas Silicone-Silver Penile Prosthesis during or after surgery?
While the device is designed for single-use implantation, postoperative care follows standard medical guidelines for penile prosthesis recovery. The silver-infused silicone material is intended to reduce infection risk, but patients should adhere to prescribed wound care and follow-up protocols. No MRI safety data is provided, so patients should avoid MRI scans post-implantation unless explicitly advised otherwise by their clinician.