Kyphoplasty systems
Synth Bes
A device designed to inflate and regulate the pressure of the balloon of a catheter, endoscopic overtube, or other invasive device (e.g., tamp, endomicroscopy probe), typically by injecting and aspirating fluid or air within the balloon, and to deflate the balloon during a medical procedure. It typically consists of a dedicated manual syringe/plunger or electronic mechanism for inflation/deflation, an analogue or digital gauge/screen for monitoring pressure, a locking mechanism, and a connecting tube. This is a single-use device.
Where to buy Synth Bes
We do not have contact details for Imedicom Co., Ltd. yet. Send a request and we will route it to the right person for your country.
Synth Bes models and sizes
From the FDA Global Unique Device Identification Database. Confirm with the manufacturer's instructions for use.
| Model / catalog no. | Size | MRI | Status |
|---|---|---|---|
| SYNTH-BES10 | — | Not stated | Available |
| SYNTH-BES15 | — | Not stated | Available |
| SYNTH-BES20 | — | Not stated | Available |
| SYNTH-BESX | — | Not stated | Available |
| SYNTH BES10 | — | Not stated | Available |
| SYNTH BES15 | — | Not stated | Available |
| SYNTH BES20 | — | Not stated | Available |
| SYNTH BESX | — | Not stated | Available |
FDA clearances
- 510(k) K153296 July 2016
Procedures that use kyphoplasty systems
Frequently asked questions
What is Synth Bes used for?
A device designed to inflate and regulate the pressure of the balloon of a catheter, endoscopic overtube, or other invasive device (e.g., tamp, endomicroscopy probe), typically by injecting and aspirating fluid or air within the balloon, and to deflate the balloon during a medical procedure. It typically consists of a dedicated manual syringe/plunger or electronic mechanism for inflation/deflation, an analogue or digital gauge/screen for monitoring pressure, a locking mechanism, and a connecting tube. This is a single-use device.
Who makes Synth Bes?
Synth Bes is made by Imedicom Co., Ltd.. It is listed under vertebral augmentation systems (kyphoplasty and vertebroplasty) in our device library.
What sizes does Synth Bes come in?
The FDA device database does not list sizes for Synth Bes. Check the instructions for use or ask a Imedicom Co., Ltd. representative.
Is Synth Bes MRI safe?
The FDA device database entry for Synth Bes does not state its MRI safety status. Check the labeling before MRI.
Is Synth Bes FDA cleared?
Synth Bes is covered by FDA submission K153296.
How do I contact a Imedicom Co., Ltd. sales representative?
Imedicom Co., Ltd. has not listed representatives on LA Vascular yet. Visit the Imedicom Co., Ltd. company page for contact details.
Models, sizes and MRI status come from the FDA Global Unique Device Identification Database (GUDID); descriptions marked "provided by the manufacturer" are reviewed before publishing. Not an endorsement; follow the manufacturer's instructions for use.