K202124 is an FDA 510(k) clearance for the Aesculap PAS-Port Proximal Anastomosis System. This device is classified as 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 FDA review panel. Regulated under 21 CFR 878.4300.
| 510(k) Number | K202124 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (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 |
| Product Code | FZP — Clip, Implantable |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4300 |