MANUKATEX (K110042) - FDA 510(k) Clearance

K110042 is an FDA 510(k) clearance for the MANUKATEX. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Manuka Medical Limited (Laguna Niguel, US). The FDA issued a Cleared decision on March 24, 2011 after a review of 77 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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