NEOSALUS (K070309) - FDA 510(k) Clearance

K070309 is an FDA 510(k) clearance for the NEOSALUS. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Quinnova Pharmaceuticals (Newtown, US). The FDA issued a Cleared decision on September 12, 2008 after a review of 589 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General & Plastic Surgery submissions.

View all Quinnova Pharmaceuticals devices