K990086 - HELIDERM COLLAGEN WOUND DRESSINGS 0.5 GRAM AND 1.0 GRAM (FDA 510(k) Clearance)

K990086 is an FDA 510(k) clearance for the HELIDERM COLLAGEN WOUND DRESSINGS 0.5 GRAM AND 1.0 GRAM. Classified as Wound Dressing With Animal-derived Material(s) (product code KGN).

Submitted by Integra Lifesciences Corp. (Plainsboro, US). The FDA issued a Cleared decision on March 31, 1999 after a review of 79 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.