K970266 - KENDALL HYDROPHILIC POWDER WOUND DRESSING (FDA 510(k) Clearance)

K970266 is an FDA 510(k) clearance for the KENDALL HYDROPHILIC POWDER WOUND DRESSING. Classified as Wound Dressing With Animal-derived Material(s) (product code KGN).

Submitted by Kendall Healthcare Products Co. Div.Of Tyco Health (Mansfield, US). The FDA issued a Cleared decision on April 23, 1997 after a review of 90 days - within the typical 510(k) review window.

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 Kendall Healthcare Products Co. Div.Of Tyco Health devices