FDA 510(k)

Sturdy Autoclave Super Microm

K-Number: K231489 · 2023-06-21

Decision Date2023-06-21

Product CodeFLE

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

Sturdy Autoclave Super Microm is a medical device manufactured by Sturdy Industrial Co., Ltd.. It received FDA 510(k) clearance on 2023-06-21 under approval number K231489. 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 Sturdy Autoclave Super Microm?

Sturdy Autoclave Super Microm is a medical device that received FDA 510(k) clearance on 2023-06-21. It is manufactured by Sturdy Industrial Co., Ltd.. The 510(k) number is K231489.

When was Sturdy Autoclave Super Microm approved by the FDA?

Sturdy Autoclave Super Microm received FDA 510(k) clearance on 2023-06-21, under approval number K231489.

What company makes Sturdy Autoclave Super Microm?

Sturdy Autoclave Super Microm is manufactured by Sturdy Industrial Co., Ltd..

What is the FDA product code for Sturdy Autoclave Super Microm?

The FDA product code for Sturdy Autoclave Super Microm is FLE.

Other Devices by Sturdy Industrial Co., Ltd.

K181993STURDY Autoclave Super Microm (models SA-260MA and SA-260MA-R)

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.