K193583 - Restrata® (FDA 510(k) Clearance)

K193583 is an FDA 510(k) clearance for the Restrata®. Classified as Absorbable Synthetic Wound Dressing (product code QSZ).

Submitted by Acera Surgical, Inc. (St. Louis, US). The FDA issued a Cleared decision on September 25, 2020 after a review of 277 days - an extended review 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. Standard predicate reliance. 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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