510(k) K202124

Aesculap PAS-Port Proximal Anastomosis System by Aesculap, Inc. — Product Code FZP

K202124 is an FDA 510(k) premarket notification submitted by Aesculap, Inc. for the device "Aesculap PAS-Port Proximal Anastomosis System". The FDA issued a decision of Substantially Equivalent on September 2, 2020. The device falls under product code FZP (Clip, Implantable), a Class II device regulated under 21 CFR 878.4300. Aesculap, Inc. has at least 10 other 510(k) clearances on record.