K100591 - SORBACT (FDA 510(k) Clearance)

K100591 is an FDA 510(k) clearance for the SORBACT. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Abigo Medical AB (Fridley, US). The FDA issued a Cleared decision on January 24, 2011 after a review of 328 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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.

View all Abigo Medical AB devices