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FDA 510(k)

Aesculap PAS-Port Proximal Anastomosis System

K-Number: K202124 · 2020-09-02

Decision Date2020-09-02
Product CodeFZP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Aesculap PAS-Port Proximal Anastomosis System is the device name listed in this FDA 510(k) record. The listed applicant is Aesculap, Inc.. It received FDA 510(k) clearance on 2020-09-02 under 510(k) number K202124. The device is classified under product code FZP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Aesculap PAS-Port Proximal Anastomosis System?

Aesculap PAS-Port Proximal Anastomosis System is a medical device that received FDA 510(k) clearance on 2020-09-02. The listed applicant is Aesculap, Inc.. The 510(k) number is K202124.

When did Aesculap PAS-Port Proximal Anastomosis System receive FDA 510(k) clearance?

Aesculap PAS-Port Proximal Anastomosis System received FDA 510(k) clearance on 2020-09-02, under 510(k) number K202124.

Who is the listed applicant for Aesculap PAS-Port Proximal Anastomosis System?

The FDA 510(k) record lists Aesculap, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Aesculap PAS-Port Proximal Anastomosis System?

The FDA product code for Aesculap PAS-Port Proximal Anastomosis System is FZP.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Other records listing Aesculap, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: FZP)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.