PRONTOSAN WOUND IRRIGATION SOLUTION (K072876) - FDA 510(k) Clearance

K072876 is an FDA 510(k) clearance for the PRONTOSAN WOUND IRRIGATION SOLUTION. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by B.Braun Medical, Inc. (Allentown, US). The FDA issued a Cleared decision on June 19, 2008 after a review of 254 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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