GELX ORAL GEL (K081372) - FDA 510(k) Clearance

K081372 is an FDA 510(k) clearance for the GELX ORAL GEL. Classified as Oral Wound Dressing (product code OLR).

Submitted by Bmg Pharma, LLC (Gardnerville, US). The FDA issued a Cleared decision on February 4, 2009 after a review of 264 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 Bmg Pharma, LLC devices