| K-number | K253326 |
| Device name | Oxiplex |
| Applicant | Fziomed, Inc. |
| Product code | QVL |
| Device class | Class II |
| Decision date | May 1, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 888.3047 |
Oxiplex is a synthetic, absorbable gel made of sodium carboxymethylcellulose and polyethylene oxide, supplied sterile in a pre-filled syringe with an applicator. It is applied to nerve roots and adjacent tissues during lumbar spine surgery to reduce leg pain and neurological symptoms in adult patients undergoing discectomy.
The subject device is a 1.5 mL configuration of Oxiplex, compared to the predicate's 3 mL configuration. Both share identical intended use, type of use, anatomic location, implanted material, mechanism of action, syringe materials, applicator material, and sterile packaging. The only difference is individual volume.
Not stated in this summary.
The 1.5 mL configuration is substantially equivalent to the 3 mL predicate device because the change involves only volume without altering material formulation, processing, mechanism of action, or tissue contact. Clinical data from the predicate device study included a subset analysis comparing subjects who received 1.5 mL or less of gel, demonstrating that this lower volume does not raise different questions of safety or effectiveness.
View the full FDA submission: accessdata.fda.gov