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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 a medical device manufactured by Encision Incorporated. It received FDA 510(k) clearance on 2020-03-20 under approval 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. It is manufactured by Encision Incorporated. The 510(k) number is K191612.

When was Encision AEM Monopolar Laparoscopic Instruments and Accessories approved by the FDA?

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

What company makes Encision AEM Monopolar Laparoscopic Instruments and Accessories?

Encision AEM Monopolar Laparoscopic Instruments and Accessories is manufactured by Encision Incorporated.

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

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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