K892360 - WATER JEL STERILE GEL-SOAKED BURN DRESSING (FDA 510(k) Clearance)

K892360 is an FDA 510(k) clearance for the WATER JEL STERILE GEL-SOAKED BURN DRESSING. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Pfizer, Inc. (Ny, US). The FDA issued a Cleared decision on June 5, 1989 after a review of 60 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.