FDA 510(k)

Lexa PLUS RIS-311

K-Number: K213758 · 2022-08-19

Decision Date2022-08-19

Product CodeFLE

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

Lexa PLUS RIS-311 is a medical device manufactured by W&H Sterilization S.R.L.. It received FDA 510(k) clearance on 2022-08-19 under approval number K213758. 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 Lexa PLUS RIS-311?

Lexa PLUS RIS-311 is a medical device that received FDA 510(k) clearance on 2022-08-19. It is manufactured by W&H Sterilization S.R.L.. The 510(k) number is K213758.

When was Lexa PLUS RIS-311 approved by the FDA?

Lexa PLUS RIS-311 received FDA 510(k) clearance on 2022-08-19, under approval number K213758.

What company makes Lexa PLUS RIS-311?

Lexa PLUS RIS-311 is manufactured by W&H Sterilization S.R.L..

What is the FDA product code for Lexa PLUS RIS-311?

The FDA product code for Lexa PLUS RIS-311 is FLE.

Other Devices by W&H Sterilization S.R.L.

K172825MN-111 K223858Lexa MINI (RIS-303, RIS-305) K233504Lexa MINI (RIS-303, RIS-305)

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.