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FDA 510(k)

HelixAR Electrosurgical Generator with Argon Beam Coagulation, HelixAR Mobile Pedestal

K-Number: K172671 · 2017-10-04

ApplicantConmed Corporation
Decision Date2017-10-04
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

HelixAR Electrosurgical Generator with Argon Beam Coagulation, HelixAR Mobile Pedestal is a medical device manufactured by Conmed Corporation. It received FDA 510(k) clearance on 2017-10-04 under approval number K172671. 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 HelixAR Electrosurgical Generator with Argon Beam Coagulation, HelixAR Mobile Pedestal?

HelixAR Electrosurgical Generator with Argon Beam Coagulation, HelixAR Mobile Pedestal is a medical device that received FDA 510(k) clearance on 2017-10-04. It is manufactured by Conmed Corporation. The 510(k) number is K172671.

When was HelixAR Electrosurgical Generator with Argon Beam Coagulation, HelixAR Mobile Pedestal approved by the FDA?

HelixAR Electrosurgical Generator with Argon Beam Coagulation, HelixAR Mobile Pedestal received FDA 510(k) clearance on 2017-10-04, under approval number K172671.

What company makes HelixAR Electrosurgical Generator with Argon Beam Coagulation, HelixAR Mobile Pedestal?

HelixAR Electrosurgical Generator with Argon Beam Coagulation, HelixAR Mobile Pedestal is manufactured by Conmed Corporation.

What is the FDA product code for HelixAR Electrosurgical Generator with Argon Beam Coagulation, HelixAR Mobile Pedestal?

The FDA product code for HelixAR Electrosurgical Generator with Argon Beam Coagulation, HelixAR Mobile Pedestal 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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