K121819 - SURGICLEAR ANTIMICROBIAL CLEAR SILICONE ADHESIVE DRESSING WITH CHLORHEXIDINE AND SILVER (FDA 510(k) Clearance)

K121819 is an FDA 510(k) clearance for the SURGICLEAR ANTIMICROBIAL CLEAR SILICONE ADHESIVE DRESSING WITH CHLORHEXIDINE .... Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Covalontechnologies, Inc. (Mississauga, Ontario, CA). The FDA issued a Cleared decision on August 13, 2012 after a review of 53 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 Covalontechnologies, Inc. devices