K172598 - Coventry Topical Anesthetic Mist Spray HAZMAT FREE, Coventry Topical Anesthetic Stream Spray HAZMAT FREE (FDA 510(k) Clearance)

K172598 is an FDA 510(k) clearance for the Coventry Topical Anesthetic Mist Spray HAZMAT FREE, Coventry Topical Anesthet.... Classified as Vapocoolant Device (product code MLY).

Submitted by Itw Contamination Control Electronics (Kennesaw, US). The FDA issued a Cleared decision on April 19, 2018 after a review of 233 days - an extended review cycle.

This device falls under the Physical Medicine 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 Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

View all Itw Contamination Control Electronics devices