K023778 - DRESSSKIN (FDA 510(k) Clearance)

K023778 is an FDA 510(k) clearance for the DRESSSKIN. Classified as Wound Dressing With Animal-derived Material(s) (product code KGN).

Submitted by Tei Biosciences, Inc. (Boston, US). The FDA issued a Cleared decision on September 29, 2003 after a review of 321 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General & Plastic Surgery FDA review panel. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

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