Granudacyn® Wound Irrigation Solution

Granudacyn Wound Wash Solution is a non-sterile wound irrigation liquid composed of water, hypochlorous acid, sodium hypochlorite, and sodium chloride created through electrolysis. Under healthcare professional supervision, it is used to cleanse, irrigate, moisten, and debride various acute and chronic wounds including pressure ulcers, diabetic ulcers, burns, and post-surgical wounds, as well as to moisturize absorbent wound dressings.

The device contains the same active components (hypochlorous acid and sodium chloride) as the predicate Vashe Wound Solution, with the addition of sodium hypochlorite. Both are non-sterile, single-patient multi-use solutions applied via squeeze bottle or spray nozzle. Granudacyn offers three volumes (250ml, 500ml, 1000ml) versus Vashe's three volumes (118ml, 250ml, 473ml), and has a 28-month shelf life compared to Vashe's 24 months.

Biocompatibility was evaluated per ISO 10993-1. Preservative effectiveness testing was conducted per USP <51> to demonstrate the antimicrobial efficacy of the solution for its stated shelf life.

Substantial equivalence is supported because both devices share identical intended use (wound cleansing and irrigation), the same device classification (unclassified dressing), the same product code (FRO), and the same mechanism of action (mechanical removal of wound debris). The compositional difference—addition of sodium hypochlorite to hypochlorous acid—does not impact substantial equivalence because antimicrobial effectiveness testing confirms the preservative system meets the same USP <51> criteria. Both devices have comparable biocompatibility and perform identically in their non-sterile, multi-use application in healthcare and homecare settings.