K092232 - MODIFICATION TO:VASHE WOUND CLEANSING SYSTEM, MODEL 9000-0014 (FDA 510(k) Clearance)

K092232 is an FDA 510(k) clearance for the MODIFICATION TO:VASHE WOUND CLEANSING 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 19, 2009 after a review of 27 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

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