K033291 - TOPSEAL HEMOSTATIC DRESSING, MODEL 11150 (FDA 510(k) Clearance)

K033291 is an FDA 510(k) clearance for the TOPSEAL HEMOSTATIC DRESSING, MODEL 11150. Classified as Hemostatic Wound Dressing Without Thrombin Or Other Biologics (product code QSY).

Submitted by Radi Medical Systems AB (Uppsala, SE). The FDA issued a Cleared decision on March 17, 2004 after a review of 155 days - an extended review cycle.

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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