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FDA 510(k)

Sterile Products of the APTUS System

K-Number: K232144 · 2023-08-18

ApplicantMedartis AG
Decision Date2023-08-18
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Sterile Products of the APTUS System is a medical device manufactured by Medartis AG. It received FDA 510(k) clearance on 2023-08-18 under approval number K232144. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Sterile Products of the APTUS System?

Sterile Products of the APTUS System is a medical device that received FDA 510(k) clearance on 2023-08-18. It is manufactured by Medartis AG. The 510(k) number is K232144.

When was Sterile Products of the APTUS System approved by the FDA?

Sterile Products of the APTUS System received FDA 510(k) clearance on 2023-08-18, under approval number K232144.

What company makes Sterile Products of the APTUS System?

Sterile Products of the APTUS System is manufactured by Medartis AG.

What is the FDA product code for Sterile Products of the APTUS System?

The FDA product code for Sterile Products of the APTUS System is HRS.

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Related PubMed Literature

PMID: 40246726 [Brief Discussion on the General Requirements of Quality Management System of Zhongguo yi liao qi xie za zhi = Chinese journal of medical instrumentation (2025)

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Official Source

View on FDA Database →

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

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