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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 the device name listed in this FDA 510(k) record. The listed applicant is Encision, Inc.. It received FDA 510(k) clearance on 2020-07-15 under 510(k) 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. The listed applicant is Encision, Inc.. The 510(k) number is K201018.

When did Encision AEM enTouch 2X Scissor receive FDA 510(k) clearance?

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

Who is the listed applicant for Encision AEM enTouch 2X Scissor?

The FDA 510(k) record lists Encision, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Encision, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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