Cleared Special

Aesculap PAS-Port Proximal Anastomosis System

K202124 · Aesculap, Inc. · General & Plastic Surgery
Sep 2020
Decision
33d
Days
Class 2
Risk

About This 510(k) Submission

K202124 is an FDA 510(k) clearance for the Aesculap PAS-Port Proximal Anastomosis System, a Clip, Implantable (Class II — Special Controls, product code FZP), submitted by Aesculap, Inc. (Center Valley, US). The FDA issued a Cleared decision on September 2, 2020, 33 days after receiving the submission on July 31, 2020. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4300.

Submission Details

510(k) Number K202124 FDA.gov
FDA Decision Cleared SESE
Date Received July 31, 2020
Decision Date September 02, 2020
Days to Decision 33 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF

Device Classification

Product Code FZP — Clip, Implantable
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.4300

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