K071442 - SUPRASORB A +AG (FDA 510(k) Clearance)

K071442 is an FDA 510(k) clearance for the SUPRASORB A +AG. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Specialty Fibres and Materials, Ltd. (Coventry, GB). The FDA issued a Cleared decision on May 1, 2008 after a review of 344 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.

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