K103793 - DURAFIBER AG (FDA 510(k) Clearance)

K103793 is an FDA 510(k) clearance for the DURAFIBER AG. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Smith & Nephew, Inc. (St Petersburg, US). The FDA issued a Cleared decision on May 2, 2011 after a review of 126 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Smith & Nephew, Inc. devices