K143527 - IPM Wound Gel Bio, IPM Derm Gel Bio (FDA 510(k) Clearance)

K143527 is an FDA 510(k) clearance for the IPM Wound Gel Bio, IPM Derm Gel Bio. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Glycobiosciences, Inc. (Georgetown, CA). The FDA issued a Cleared decision on April 20, 2015 after a review of 129 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.

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