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 (FDA 510(k) Clearance)

K172486 is an FDA 510(k) clearance for the Anexa Wound Flush, USP Sterile Water, and USP Sterile Normal Saline (0.9% sod.... Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Anexa Biomedical, Inc. (Zephyrhills, US). The FDA issued a Cleared decision on September 21, 2017 after a review of 35 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

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