HaloGUARD Protective Disc with CHG (K200641) - FDA 510(k) Clearance

K200641 is an FDA 510(k) clearance for the HaloGUARD Protective Disc with CHG. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Attwill Medical Solutions (Lodi, US). The FDA issued a Cleared decision on September 3, 2020 after a review of 176 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Attwill Medical Solutions devices