510(k) K172486

Anexa Wound Flush, USP Sterile Water, and USP Sterile Normal Saline (0.9% sodium chloride) 120 mL cup, USP Sterile Water, and USP Sterile Normal Saline (0.9% sodium chloride) 100mL bottle, USP Sterile Water, and USP Sterile Normal Saline (0.9% sodium chloride) 250mL bottle, USP Sterile Water, and USP Sterile Normal Saline (0.9% sodium chloride) 500mL bottle by Anexa Biomedical, Inc. — Product Code FRO

K172486 is an FDA 510(k) premarket notification submitted by Anexa Biomedical, Inc. for the device "Anexa Wound Flush, USP Sterile Water, and USP Sterile Normal Saline (0.9% sodium chloride) 120 mL cup, USP Sterile Water, and USP Sterile Normal Saline (0.9% sodium chloride) 100mL bottle, USP Sterile Water, and USP Sterile Normal Saline (0.9% sodium chloride) 250mL bottle, USP Sterile Water, and USP Sterile Normal Saline (0.9% sodium chloride) 500mL bottle". The FDA issued a decision of Substantially Equivalent on Sep 21, 2017. The device falls under product code FRO (Dressing, Wound, Drug), a Class U device. Anexa Biomedical, Inc. has 1 other 510(k) clearance on record.