K141382 - BIOS KING BIOCELLULOSE FILM (FDA 510(k) Clearance)

K141382 is an FDA 510(k) clearance for the BIOS KING BIOCELLULOSE FILM. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Coreleader Biotech Co., Ltd. (New Taipei City, TW). The FDA issued a Cleared decision on February 10, 2015 after a review of 259 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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