FDA 510(k)

Getinge GSS67N Series Steam Sterilizer

K-Number: K252307 · 2026-01-22

ApplicantMaquet GmbH (A Getinge Group Company)

Decision Date2026-01-22

Product CodeFLE

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

Getinge GSS67N Series Steam Sterilizer is a medical device manufactured by Maquet GmbH (A Getinge Group Company). It received FDA 510(k) clearance on 2026-01-22 under approval number K252307. 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 GSS67N Series Steam Sterilizer?

Getinge GSS67N Series Steam Sterilizer is a medical device that received FDA 510(k) clearance on 2026-01-22. It is manufactured by Maquet GmbH (A Getinge Group Company). The 510(k) number is K252307.

When was Getinge GSS67N Series Steam Sterilizer approved by the FDA?

Getinge GSS67N Series Steam Sterilizer received FDA 510(k) clearance on 2026-01-22, under approval number K252307.

What company makes Getinge GSS67N Series Steam Sterilizer?

Getinge GSS67N Series Steam Sterilizer is manufactured by Maquet GmbH (A Getinge Group Company).

What is the FDA product code for Getinge GSS67N Series Steam Sterilizer?

The FDA product code for Getinge GSS67N Series Steam Sterilizer is FLE.

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.