PuraStat

PuraStat is a sterile gel hemostatic device composed of a synthetic peptide and sterile water for injection, delivered via a prefilled syringe through an endoscopic catheter. It is intended for hemostasis of mild to moderate bleeding following endoscopic procedures (ESD/EMR), as an adjunct or prophylactic therapy for intraprocedural venous bleeding, and for primary non-variceal gastrointestinal bleeding, but is not indicated for arterial Forrest 1a bleeding.

The modified PuraStat is identical to the predicate device (K242250) in material composition, formulation, and core manufacturing steps, with the exception of an additional sterilization method (ethylene oxide) and minor differences in packaging and syringe components. The device forms a transparent hydrogel matrix upon exposure to blood that blocks bleeding without volume expansion.

ISO 11137 (gamma sterilization validation), ISO 11607 (packaging validation), ISO 10993-1 (biocompatibility), ISO 11135 (EtO sterilization validation), and ISO 10993-7 (EO/ECH residual analysis).

The modified PuraStat is substantially equivalent to the predicate because it has identical intended use, indications, materials, formulation, and manufacturing processes, with only minor changes in sterilization method and packaging/syringe components that do not raise new safety or effectiveness concerns. All performance testing confirms equivalence using identical methods and acceptance criteria as the predicate device.