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FDA 510(k)

Encision AEM Monopolar Laparoscopic Instruments and Accessories

K-Number: K191612 · 2020-03-20

ApplicantEncision Incorporated
Decision Date2020-03-20
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Encision AEM Monopolar Laparoscopic Instruments and Accessories is the device name listed in this FDA 510(k) record. The listed applicant is Encision Incorporated. It received FDA 510(k) clearance on 2020-03-20 under 510(k) number K191612. 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 Monopolar Laparoscopic Instruments and Accessories?

Encision AEM Monopolar Laparoscopic Instruments and Accessories is a medical device that received FDA 510(k) clearance on 2020-03-20. The listed applicant is Encision Incorporated. The 510(k) number is K191612.

When did Encision AEM Monopolar Laparoscopic Instruments and Accessories receive FDA 510(k) clearance?

Encision AEM Monopolar Laparoscopic Instruments and Accessories received FDA 510(k) clearance on 2020-03-20, under 510(k) number K191612.

Who is the listed applicant for Encision AEM Monopolar Laparoscopic Instruments and Accessories?

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

What is the FDA product code for Encision AEM Monopolar Laparoscopic Instruments and Accessories?

The FDA product code for Encision AEM Monopolar Laparoscopic Instruments and Accessories is GEI.

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Official Source

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