Biosphere Medical, S.A. · Class II · Cleared May 16, 2025
| K-number | K250971 |
| Device name | Embosphere Microspheres |
| Applicant | Biosphere Medical, S.A. |
| Product code | KRD |
| Device class | Class II |
| Decision date | May 16, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 870.3300 |
Embosphere Microspheres are small, compressible, hydrophilic spheres made of acrylic polymer and porcine-derived gelatin, suspended in 0.9% saline. They are used for vascular embolization to occlude blood flow in hypervascular tumors (including uterine fibroids), prostatic arteries for benign prostatic hyperplasia, arteriovenous malformations, and peripheral bleeding. The device is available in seven size ranges from 50–1200 microns and is delivered via microcatheter under fluoroscopic guidance.
The subject device is technologically identical to the predicate device (K181300) in design, materials, manufacturing, processing, and sterilization. The sole difference is an addition to the Instructions for Use contraindications section to contraindicate use in pulmonary arteries.
Not stated in this summary.
The device is substantially equivalent because it has identical indications for use, design, materials, and manufacturing processes as the predicate Embosphere Microspheres (K181300). The only change is a labeling addition restricting use in pulmonary arteries, which does not alter the device's technological characteristics or introduce new safety and effectiveness concerns. No new testing was performed because the subject and predicate devices are identical except for this contraindication clarification.
View the full FDA submission: accessdata.fda.gov