K122886 - NEXSTAT PLUS AND NEXFOAM PLUS TOPICAL HEMOSTAT DRESSING (FDA 510(k) Clearance)

K122886 is an FDA 510(k) clearance for the NEXSTAT PLUS AND NEXFOAM PLUS TOPICAL HEMOSTAT DRESSING. Classified as Hemostatic Wound Dressing Without Thrombin Or Other Biologics (product code QSY).

Submitted by Hemostasis, LLC (St. Paul, US). The FDA issued a Cleared decision on November 15, 2012 after a review of 56 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.

View all Hemostasis, LLC devices