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FDA 510(k)

ABI Instrument, Creo Electrosurgical System

K-Number: K200298 · 2021-01-05

ApplicantCreo Medical, Ltd.
Decision Date2021-01-05
Product CodeNEY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ABI Instrument, Creo Electrosurgical System is a medical device manufactured by Creo Medical, Ltd.. It received FDA 510(k) clearance on 2021-01-05 under approval number K200298. The device is classified under product code NEY. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ABI Instrument, Creo Electrosurgical System?

ABI Instrument, Creo Electrosurgical System is a medical device that received FDA 510(k) clearance on 2021-01-05. It is manufactured by Creo Medical, Ltd.. The 510(k) number is K200298.

When was ABI Instrument, Creo Electrosurgical System approved by the FDA?

ABI Instrument, Creo Electrosurgical System received FDA 510(k) clearance on 2021-01-05, under approval number K200298.

What company makes ABI Instrument, Creo Electrosurgical System?

ABI Instrument, Creo Electrosurgical System is manufactured by Creo Medical, Ltd..

What is the FDA product code for ABI Instrument, Creo Electrosurgical System?

The FDA product code for ABI Instrument, Creo Electrosurgical System is NEY.

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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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