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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 the device name listed in this FDA 510(k) record. The listed applicant is Conmed Corporation. It received FDA 510(k) clearance on 2017-10-04 under 510(k) 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. The listed applicant is Conmed Corporation. The 510(k) number is K172671.

When did HelixAR Electrosurgical Generator with Argon Beam Coagulation, HelixAR Mobile Pedestal receive FDA 510(k) clearance?

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

Who is the listed applicant for HelixAR Electrosurgical Generator with Argon Beam Coagulation, HelixAR Mobile Pedestal?

The FDA 510(k) record lists Conmed Corporation as the applicant. This does not by itself establish the device manufacturer.

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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