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FDA 510(k)

Encision AEM enTouch 2X Scissor

K-Number: K201018 · 2020-07-15

ApplicantEncision, Inc.
Decision Date2020-07-15
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Encision AEM enTouch 2X Scissor is a medical device manufactured by Encision, Inc.. It received FDA 510(k) clearance on 2020-07-15 under approval number K201018. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Encision AEM enTouch 2X Scissor?

Encision AEM enTouch 2X Scissor is a medical device that received FDA 510(k) clearance on 2020-07-15. It is manufactured by Encision, Inc.. The 510(k) number is K201018.

When was Encision AEM enTouch 2X Scissor approved by the FDA?

Encision AEM enTouch 2X Scissor received FDA 510(k) clearance on 2020-07-15, under approval number K201018.

What company makes Encision AEM enTouch 2X Scissor?

Encision AEM enTouch 2X Scissor is manufactured by Encision, Inc..

What is the FDA product code for Encision AEM enTouch 2X Scissor?

The FDA product code for Encision AEM enTouch 2X Scissor is GEI.

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Official Source

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