K131796 - MANUKA FILL WOUND DRESSING (FDA 510(k) Clearance)

K131796 is an FDA 510(k) clearance for the MANUKA FILL WOUND DRESSING. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Links Medical Products, Inc. (Laguna Niguel, US). The FDA issued a Cleared decision on March 14, 2014 after a review of 269 days - an extended review 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: 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 Links Medical Products, Inc. devices