THERAFORM BILAYER (K090823) - FDA 510(k) Clearance

K090823 is an FDA 510(k) clearance for the THERAFORM BILAYER. Classified as Wound Dressing With Animal-derived Material(s) (product code KGN).

Submitted by Sewon Cellontech Co., Ltd. (Santa Fe Springs, US). The FDA issued a Cleared decision on October 22, 2009 after a review of 210 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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