Complex sentence: PrePex is cleared by the U.S. Food and Drug Administration (FDA), certified under the 510 (k) mechanism with Smart Klamp as the predicate device Mark Class IIa device and is available for adult men.
Split into simpler sentences: PrePex is cleared by the U.S. Food and Drug Administration (FDA), certified under the 510 (k) mechanism with Smart Klamp as the predicate device. It is a Mark Class IIa device and is available for adult men.