K993948 - SIS WOUND DRESSING II (FDA 510(k) Clearance)

K993948 is an FDA 510(k) clearance for the SIS WOUND DRESSING II. Classified as Wound Dressing With Animal-derived Material(s) (product code KGN).

Submitted by Cook Biotech, Inc. (West Lafayette, US). The FDA issued a Cleared decision on January 6, 2000 after a review of 45 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.

View all Cook Biotech, Inc. devices