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FDA 510(k)

Single Use Electrosurgical Knife with Fluid Pump System

K-Number: K211172 · 2021-12-17

ApplicantMicro-Tech (Nanjing) Co., Ltd.
Decision Date2021-12-17
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Single Use Electrosurgical Knife with Fluid Pump System 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 2021-12-17 under 510(k) number K211172. 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 with Fluid Pump System?

Single Use Electrosurgical Knife with Fluid Pump System is a medical device that received FDA 510(k) clearance on 2021-12-17. The listed applicant is Micro-Tech (Nanjing) Co., Ltd.. The 510(k) number is K211172.

When did Single Use Electrosurgical Knife with Fluid Pump System receive FDA 510(k) clearance?

Single Use Electrosurgical Knife with Fluid Pump System received FDA 510(k) clearance on 2021-12-17, under 510(k) number K211172.

Who is the listed applicant for Single Use Electrosurgical Knife with Fluid Pump System?

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 with Fluid Pump System?

The FDA product code for Single Use Electrosurgical Knife with Fluid Pump System 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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