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FDA 510(k)

SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900

K-Number: K230582 · 2023-03-28

Decision Date2023-03-28
Product CodeMED
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900 is the device name listed in this FDA 510(k) record. The listed applicant is STERIS Corporation. It received FDA 510(k) clearance on 2023-03-28 under 510(k) number K230582. The device is classified under product code MED. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900?

SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900 is a medical device that received FDA 510(k) clearance on 2023-03-28. The listed applicant is STERIS Corporation. The 510(k) number is K230582.

When did SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900 receive FDA 510(k) clearance?

SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900 received FDA 510(k) clearance on 2023-03-28, under 510(k) number K230582.

Who is the listed applicant for SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900?

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

What is the FDA product code for SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900?

The FDA product code for SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900 is MED.

Other records listing STERIS Corporation 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: MED)

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.