K894541 - CARRINGTON DERMAL WOUND GEL

K894541 is an FDA 510(k) clearance for the CARRINGTON DERMAL WOUND GEL. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Carrington Laboratories, Inc. (Dallas, US). The FDA issued a Cleared decision on November 30, 1989 after a review of 133 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.