K083042 - WOUND FLUSH, STERILE WATER & NORMAL SALINE (FDA 510(k) Clearance)

K083042 is an FDA 510(k) clearance for the WOUND FLUSH, STERILE WATER & NORMAL SALINE. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Nurse Assist, Inc. (Carrollton, US). The FDA issued a Cleared decision on December 18, 2008 after a review of 65 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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