Catasyn Advanced Technology Wound Hydrogel (K172338) - FDA 510(k) Clearance

K172338 is an FDA 510(k) clearance for the Catasyn Advanced Technology Wound Hydrogel. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Synedgen, Inc. (Claremont, US). The FDA issued a Cleared decision on February 21, 2018 after a review of 203 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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