K191536 - Biatain Silicone Ag (FDA 510(k) Clearance)

K191536 is an FDA 510(k) clearance for the Biatain Silicone Ag. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Coloplast A/S (Humlebaek, DK). The FDA issued a Cleared decision on February 21, 2020 after a review of 256 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.

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