Constrictor Ring for Penile Erection

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K891125 ↗

FDA Product Code

LKY

Device Class

Class II

Regulation

21 CFR Part 876.5020

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• What is the primary purpose of this constrictor ring, and how does it work?

  This constrictor ring is designed as an external penile rigidity aid to help maintain an erection by restricting venous outflow. After achieving an erection through natural means, the ring is placed around the base of the penis to prevent blood from draining out, thereby preserving rigidity for extended periods. It is specifically intended for use in treating erectile dysfunction or conditions involving venous leak.

• Is this device sterile, and how should it be handled before use?

  The constrictor ring is supplied as a non-sterile single-use device. Since it is not sterile, it should be handled with care to avoid contamination before application. If used in a clinical setting, standard aseptic techniques should be followed to minimize the risk of infection, though the device itself does not require sterilization.

• Are there multiple sizes or models available, and how are they differentiated?

  Yes, this device comes in multiple variants, each identified by unique FEI (Federal Equipment Identifier) numbers. While the exact dimensions are not detailed in the regulatory data, the different FEI numbers (e.g., 3016028125, 3015200846, etc.) likely correspond to variations in size or design to accommodate different patient anatomies. The specific sizing should be confirmed with the manufacturer or product documentation.

• How is this device regulated, and what does that mean for its use?

  This constrictor ring is regulated under FDA 510(k) clearance (K891125) and falls under Class II medical devices (regulation number 876.5020). The clearance indicates it has been deemed substantially equivalent to a legally marketed device already on the market, meaning it meets FDA safety and effectiveness standards. Clinicians and users should follow the manufacturer’s instructions and any applicable clinical guidelines when applying it.

• Can this device be reused, or is it intended for single-use only?

  The device is explicitly labeled as single-use only. Reusing it could compromise its effectiveness and increase the risk of infection or irritation, so it should not be reused after one application. Proper disposal after use is recommended to maintain hygiene and safety.