E-Z DERM BIOSYNTHETIC WOUND DRESSING (K935189) - FDA 510(k) Clearance

K935189 is an FDA 510(k) clearance for the E-Z DERM BIOSYNTHETIC WOUND DRESSING. Classified as Wound Dressing With Animal-derived Material(s) (product code KGN).

Submitted by Brennen Medical, Inc. (St. Paul, US). The FDA issued a Cleared decision on July 11, 1994 after a review of 258 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.

View all Brennen Medical, Inc. devices