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FDA 510(k)

Single Use Electrosurgical Knife

K-Number: K193601 · 2020-07-24

ApplicantMicro-Tech (Nanjing) Co., Ltd.
Decision Date2020-07-24
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Single Use Electrosurgical Knife is a medical device manufactured by Micro-Tech (Nanjing) Co., Ltd.. It received FDA 510(k) clearance on 2020-07-24 under approval number K193601. 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 Single Use Electrosurgical Knife?

Single Use Electrosurgical Knife is a medical device that received FDA 510(k) clearance on 2020-07-24. It is manufactured by Micro-Tech (Nanjing) Co., Ltd.. The 510(k) number is K193601.

When was Single Use Electrosurgical Knife approved by the FDA?

Single Use Electrosurgical Knife received FDA 510(k) clearance on 2020-07-24, under approval number K193601.

What company makes Single Use Electrosurgical Knife?

Single Use Electrosurgical Knife is manufactured by Micro-Tech (Nanjing) Co., Ltd..

What is the FDA product code for Single Use Electrosurgical Knife?

The FDA product code for Single Use Electrosurgical Knife is GEI.

Related Clinical Trials

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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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