| K-number | K242634 |
| Device name | PuraStat |
| Applicant | 3-D Matrix Europe SAS |
| Product code | PHN |
| Device class | Class U |
| Decision date | Jan 15, 2025 |
| Decision | Substantially Equivalent |
| Regulation | — |
PuraStat is a sterile gel composed of a synthetic peptide (RADA-16 oligopeptide) and sterile water, delivered as a prefilled syringe via endoscopic catheter. It is indicated for symptomatic management of rectal mucositis, such as radiation proctitis caused by chemotherapy or radiotherapy, by forming a protective barrier over the rectal mucosa when exposed to physiological fluids.
PuraStat is identical to the predicate PuraStat-RM (K213552) in material, formulation, and manufacturing, with one difference: the final sterilization method is changed from ethylene oxide to gamma radiation. Final product specifications remain unchanged. The device comprises a 2.5% peptide content in sterile water, filled into 1, 3, or 5 mL syringes with polyethylene plungers and butyl rubber head caps and gaskets.
Not stated in this summary.
The subject device has identical intended use and indications for use as the predicate K213552. Although the final sterilization method differs (gamma radiation versus ethylene oxide), bench testing and biocompatibility testing demonstrate equivalence and raise no new safety or effectiveness questions. Since the material, formulation, and product specifications are identical to the predicate, and the sterilization change does not affect the final product characteristics, the device is substantially equivalent.
View the full FDA submission: accessdata.fda.gov