FDA 510(k)

STATCLAVE G4 Chamber Autoclave

K-Number: K190062 · 2019-07-26

Decision Date2019-07-26

Product CodeFLE

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

STATCLAVE G4 Chamber Autoclave is a medical device manufactured by Scican , Ltd.. It received FDA 510(k) clearance on 2019-07-26 under approval number K190062. 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 STATCLAVE G4 Chamber Autoclave?

STATCLAVE G4 Chamber Autoclave is a medical device that received FDA 510(k) clearance on 2019-07-26. It is manufactured by Scican , Ltd.. The 510(k) number is K190062.

When was STATCLAVE G4 Chamber Autoclave approved by the FDA?

STATCLAVE G4 Chamber Autoclave received FDA 510(k) clearance on 2019-07-26, under approval number K190062.

What company makes STATCLAVE G4 Chamber Autoclave?

STATCLAVE G4 Chamber Autoclave is manufactured by Scican , Ltd..

What is the FDA product code for STATCLAVE G4 Chamber Autoclave?

The FDA product code for STATCLAVE G4 Chamber Autoclave is FLE.

Other Devices by Scican , Ltd.

K172292SALUS - Hygiene Instrument Reprocessing Container K192910STATClave G4 Chamber Autoclave K210326Bravo G4 Chamber Autoclave K214057STATIM 6000B Vacuum Autoclave

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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.