FDA 510(k)

ST-Z5

K-Number: K201878 · 2021-03-25

Decision Date2021-03-25

Product CodeKCT

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

ST-Z5 is the device name listed in this FDA 510(k) record. The listed applicant is Z-Systems AG. It received FDA 510(k) clearance on 2021-03-25 under 510(k) number K201878. The device is classified under product code KCT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ST-Z5?

ST-Z5 is a medical device that received FDA 510(k) clearance on 2021-03-25. The listed applicant is Z-Systems AG. The 510(k) number is K201878.

When did ST-Z5 receive FDA 510(k) clearance?

ST-Z5 received FDA 510(k) clearance on 2021-03-25, under 510(k) number K201878.

Who is the listed applicant for ST-Z5?

The FDA 510(k) record lists Z-Systems AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ST-Z5?

The FDA product code for ST-Z5 is KCT.

Other records listing Z-Systems AG 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.

K201712Z5-TL K200386Z5-BL K190243Z5-BL

Related Devices (Code: KCT)

K253187SteriBest® Sterilization Tray SystemMastel Surgical K260726Straumann® ProClean™ Cassette (041.800 ; 041.801)Institut Straumann AG K252854SteriTite Container System with MediTray ProductsCase Medical, Inc.K253791PUREVUE™ Quick Connect Cannula System Tray; PUREVUE™ Quick Connect Cannula System LidDePuy Mitek, Inc.K251614Stainless Steel Surgical KitsDentsply Sirona, Inc.K251756Sterilization TraysParagon Implant Mfg., LLC

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.