510(k) K161658

Anexa Wound Flush, Sterile Water & Sterile Normal Saline by Anexa Biomedical, Inc. — Product Code FRO

K161658 is an FDA 510(k) premarket notification submitted by Anexa Biomedical, Inc. for the device "Anexa Wound Flush, Sterile Water & Sterile Normal Saline". The FDA issued a decision of Substantially Equivalent on Sep 14, 2016. 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.