FDA 510(k)

GSS610N21 Series Steam Sterilizer

K-Number: K214120 · 2022-05-18

Decision Date2022-05-18

Product CodeFLE

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

GSS610N21 Series Steam Sterilizer is a medical device manufactured by Maquet GmbH. It received FDA 510(k) clearance on 2022-05-18 under approval number K214120. 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 GSS610N21 Series Steam Sterilizer?

GSS610N21 Series Steam Sterilizer is a medical device that received FDA 510(k) clearance on 2022-05-18. It is manufactured by Maquet GmbH. The 510(k) number is K214120.

When was GSS610N21 Series Steam Sterilizer approved by the FDA?

GSS610N21 Series Steam Sterilizer received FDA 510(k) clearance on 2022-05-18, under approval number K214120.

What company makes GSS610N21 Series Steam Sterilizer?

GSS610N21 Series Steam Sterilizer is manufactured by Maquet GmbH.

What is the FDA product code for GSS610N21 Series Steam Sterilizer?

The FDA product code for GSS610N21 Series Steam Sterilizer is FLE.

Other Devices by Maquet GmbH

K172159Getinge GSS67N Series Steam Sterilizer K201927Getinge GSS610N 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

View on FDA Database →

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