| K-number | K253923 |
| Device name | PuraStat |
| Applicant | 3-D Matrix Europe SAS |
| Product code | PHN |
| Device class | Class U |
| Decision date | Jan 7, 2026 |
| Decision | Substantially Equivalent |
| Regulation | — |
PuraStat is a sterile gel composed of a synthetic peptide and sterile water for injection, delivered via a prefilled syringe through an endoscopic catheter. It forms a protective barrier over the rectal mucosa and is indicated for symptomatic management of rectal mucositis, such as radiation proctitis caused by chemotherapy or radiotherapy.
The modified PuraStat is identical in material, formulation, and manufacturing steps to the predicate device, with differences limited to the sterilization method (EtO instead of gamma) and minor packaging and syringe component changes. The device remains a 2.5% peptide content hydrogel that is non-animal and non-plant derived with no preservatives.
ISO 11137 (gamma sterilization validation), ISO 11135 (EtO sterilization validation), ISO 10993-1 (biocompatibility), ISO 10993-7 (EO/ECH residual analysis), and ISO 11607 (packaging validation).
The modified PuraStat is substantially equivalent to the predicate PuraStat (K242634) because the technological characteristics are identical except for the sterilization method and minor packaging differences, which do not raise safety or effectiveness concerns. Performance testing confirms the device maintains the same material, formulation, and final product specifications as the predicate.
View the full FDA submission: accessdata.fda.gov