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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 the device name listed in this FDA 510(k) record. The listed applicant is Micro-Tech (Nanjing) Co., Ltd.. It received FDA 510(k) clearance on 2020-07-24 under 510(k) 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. The listed applicant is Micro-Tech (Nanjing) Co., Ltd.. The 510(k) number is K193601.

When did Single Use Electrosurgical Knife receive FDA 510(k) clearance?

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

Who is the listed applicant for Single Use Electrosurgical Knife?

The FDA 510(k) record lists Micro-Tech (Nanjing) Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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

The FDA product code for Single Use Electrosurgical Knife 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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