K190756 - IODOFLEX (FDA 510(k) Clearance)

K190756 is an FDA 510(k) clearance for the IODOFLEX. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Smith & Nephew Medical, Ltd. (Hull East Riding Of Yorkshire, GB). The FDA issued a Cleared decision on December 20, 2019 after a review of 270 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.

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