K954621 - RECLOSABLE WOUND COVER (FDA 510(k) Clearance)

K954621 is an FDA 510(k) clearance for the RECLOSABLE WOUND COVER. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Hollister, Inc. (Libertyville, US). The FDA issued a Cleared decision on October 23, 1995 after a review of 18 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 Hollister, Inc. devices