K000487 - MEDTRADE PRODUCTS ALGINATE ISLAND (FDA 510(k) Clearance)

K000487 is an FDA 510(k) clearance for the MEDTRADE PRODUCTS ALGINATE ISLAND. Classified as Wound Dressing With Animal-derived Material(s) (product code KGN).

Submitted by Medtrade Products , Ltd. (Crewe, GB). The FDA issued a Cleared decision on April 18, 2000 after a review of 64 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.

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