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FDA 510(k)

SterilContainer S2 System

K-Number: K193582 · 2020-03-17

Decision Date2020-03-17
Product CodeKCT
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SterilContainer S2 System is a medical device manufactured by Aesculap, Inc.. It received FDA 510(k) clearance on 2020-03-17 under approval number K193582. 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 SterilContainer S2 System?

SterilContainer S2 System is a medical device that received FDA 510(k) clearance on 2020-03-17. It is manufactured by Aesculap, Inc.. The 510(k) number is K193582.

When was SterilContainer S2 System approved by the FDA?

SterilContainer S2 System received FDA 510(k) clearance on 2020-03-17, under approval number K193582.

What company makes SterilContainer S2 System?

SterilContainer S2 System is manufactured by Aesculap, Inc..

What is the FDA product code for SterilContainer S2 System?

The FDA product code for SterilContainer S2 System is KCT.

Other Devices by Aesculap, Inc.

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Related Devices (Code: KCT)

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.