EPISIL (K101769) - FDA 510(k) Clearance

K101769 is an FDA 510(k) clearance for the EPISIL. Classified as Oral Wound Dressing (product code OLR).

Submitted by Camurus AB (North Reading, US). The FDA issued a Cleared decision on September 13, 2011 after a review of 446 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.

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