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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 a medical device manufactured by Micro-Tech (Nanjing) Co., Ltd.. It received FDA 510(k) clearance on 2021-12-17 under approval 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. It is manufactured by Micro-Tech (Nanjing) Co., Ltd.. The 510(k) number is K211172.

When was Single Use Electrosurgical Knife with Fluid Pump System approved by the FDA?

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

What company makes Single Use Electrosurgical Knife with Fluid Pump System?

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

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.

Related Clinical Trials

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Related PubMed Literature

PMID: 41529615 Wearable microneedle sensors for continuous interstitial fluid monitoring. Biosensors & bioelectronics (2026) PMID: 40258332 Chronic expanding hematoma following Gamma Knife irradiation for primary central nervous system lymphoma: illustrative case. Journal of neurosurgery. Case lessons (2025)

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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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