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FDA 510(k)

AB1 Electrosurgical Instrument, Creo Electrosurgical System

K-Number: K223138 · 2023-06-26

ApplicantCreo Medical, Ltd.
Decision Date2023-06-26
Product CodeNEY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

AB1 Electrosurgical Instrument, Creo Electrosurgical System is a medical device manufactured by Creo Medical, Ltd.. It received FDA 510(k) clearance on 2023-06-26 under approval number K223138. 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 AB1 Electrosurgical Instrument, Creo Electrosurgical System?

AB1 Electrosurgical Instrument, Creo Electrosurgical System is a medical device that received FDA 510(k) clearance on 2023-06-26. It is manufactured by Creo Medical, Ltd.. The 510(k) number is K223138.

When was AB1 Electrosurgical Instrument, Creo Electrosurgical System approved by the FDA?

AB1 Electrosurgical Instrument, Creo Electrosurgical System received FDA 510(k) clearance on 2023-06-26, under approval number K223138.

What company makes AB1 Electrosurgical Instrument, Creo Electrosurgical System?

AB1 Electrosurgical Instrument, Creo Electrosurgical System is manufactured by Creo Medical, Ltd..

What is the FDA product code for AB1 Electrosurgical Instrument, Creo Electrosurgical System?

The FDA product code for AB1 Electrosurgical 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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