FDA 510(k)

Getinge GSS610N Series Steam Sterilizer

K-Number: K201927 · 2021-03-01

Decision Date2021-03-01

Product CodeFLE

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

Getinge GSS610N Series Steam Sterilizer is a medical device manufactured by Maquet GmbH. It received FDA 510(k) clearance on 2021-03-01 under approval number K201927. The device is classified under product code FLE. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Getinge GSS610N Series Steam Sterilizer?

Getinge GSS610N Series Steam Sterilizer is a medical device that received FDA 510(k) clearance on 2021-03-01. It is manufactured by Maquet GmbH. The 510(k) number is K201927.

When was Getinge GSS610N Series Steam Sterilizer approved by the FDA?

Getinge GSS610N Series Steam Sterilizer received FDA 510(k) clearance on 2021-03-01, under approval number K201927.

What company makes Getinge GSS610N Series Steam Sterilizer?

Getinge GSS610N Series Steam Sterilizer is manufactured by Maquet GmbH.

What is the FDA product code for Getinge GSS610N Series Steam Sterilizer?

The FDA product code for Getinge GSS610N Series Steam Sterilizer is FLE.

Other Devices by Maquet GmbH

K172159Getinge GSS67N Series Steam Sterilizer K214120GSS610N21 Series Steam Sterilizer

Related Devices (Code: FLE)

K151597Family of Steam Sterilizers B 28 seriesCefla S.C. K163337Midmark and Ritter M9 and M11 UltraClave® Automatic Sterilizers and Ritter M9D AutoClave® Automatic SterilizerMidmark Corporation K170228Belimed Steam Sterilizer MST-H TOP 5000Belimed AG K161848Family of Steam sterilizers B17 B22 SeriesCefla S.C. K180272Saniclave 250Revolutionary Science K172825MN-111W&H Sterilization S.R.L.

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.