FDA 510(k)

STATIM 6000B Vacuum Autoclave

K-Number: K214057 · 2022-03-31

Decision Date2022-03-31

Product CodeFLE

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

STATIM 6000B Vacuum Autoclave is a medical device manufactured by Scican , Ltd.. It received FDA 510(k) clearance on 2022-03-31 under approval number K214057. 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 STATIM 6000B Vacuum Autoclave?

STATIM 6000B Vacuum Autoclave is a medical device that received FDA 510(k) clearance on 2022-03-31. It is manufactured by Scican , Ltd.. The 510(k) number is K214057.

When was STATIM 6000B Vacuum Autoclave approved by the FDA?

STATIM 6000B Vacuum Autoclave received FDA 510(k) clearance on 2022-03-31, under approval number K214057.

What company makes STATIM 6000B Vacuum Autoclave?

STATIM 6000B Vacuum Autoclave is manufactured by Scican , Ltd..

What is the FDA product code for STATIM 6000B Vacuum Autoclave?

The FDA product code for STATIM 6000B Vacuum Autoclave is FLE.

Other Devices by Scican , Ltd.

K172292SALUS - Hygiene Instrument Reprocessing Container K190062STATCLAVE G4 Chamber Autoclave K192910STATClave G4 Chamber Autoclave K210326Bravo G4 Chamber Autoclave

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.