K254073 - StatSeal Disc (FDA 510(k) Clearance)

K254073 is an FDA 510(k) clearance for the StatSeal Disc. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Merit Medical Systems, Inc. (South Jordan, US). The FDA issued a Cleared decision on May 13, 2026 after a review of 146 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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