K100918 - VASHE WOUND THERAPY SYSTEM MODEL: 9000-0014 (FDA 510(k) Clearance)

K100918 is an FDA 510(k) clearance for the VASHE WOUND THERAPY SYSTEM MODEL: 9000-0014. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Puricore, Inc. (Malvern, US). The FDA issued a Cleared decision on August 9, 2010 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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