FDA 510(k)

T-Edge 10, T-Edge 11

K-Number: K213080 · 2022-01-04

Decision Date2022-01-04

Product CodeFLE

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

T-Edge 10, T-Edge 11 is a medical device manufactured by Tuttnauer , Ltd.. It received FDA 510(k) clearance on 2022-01-04 under approval number K213080. 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 T-Edge 10, T-Edge 11?

T-Edge 10, T-Edge 11 is a medical device that received FDA 510(k) clearance on 2022-01-04. It is manufactured by Tuttnauer , Ltd.. The 510(k) number is K213080.

When was T-Edge 10, T-Edge 11 approved by the FDA?

T-Edge 10, T-Edge 11 received FDA 510(k) clearance on 2022-01-04, under approval number K213080.

What company makes T-Edge 10, T-Edge 11?

T-Edge 10, T-Edge 11 is manufactured by Tuttnauer , Ltd..

What is the FDA product code for T-Edge 10, T-Edge 11?

The FDA product code for T-Edge 10, T-Edge 11 is FLE.

Other Devices by Tuttnauer , Ltd.

K181456Tuttnauer Horizontal Models:4472,5596,6690,66120,69120 and 69180 autoclaves K222608Tuttnauer Pre-vacuum Steam Sterilizer models 3870HSG and 3870HSG-WS K221227Tuttnauer Horizontal autoclave series model: 4472, 5596, 6690, 66120

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.