K854344 - AQUACEL SURGICAL PREP PADS (FDA 510(k) Clearance)

K854344 is an FDA 510(k) clearance for the AQUACEL SURGICAL PREP PADS. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Advanced Ortho-Technology, Inc. (Tuckahoe, US). The FDA issued a Cleared decision on November 13, 1985 after a review of 15 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.

View all Advanced Ortho-Technology, Inc. devices