K132105 - PERCLOT TOPICAL (FDA 510(k) Clearance)

K132105 is an FDA 510(k) clearance for the PERCLOT TOPICAL. Classified as Hemostatic Wound Dressing Without Thrombin Or Other Biologics (product code QSY).

Submitted by Cryolife, Inc. (Kennesaw, US). The FDA issued a Cleared decision on April 3, 2014 after a review of 269 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.