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FDA 510(k)

Esophagus Bougie Set

K-Number: K161576 · 2016-10-02

ApplicantVarian Medical Systems, Inc.
Decision Date2016-10-02
Product CodeJAQ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Esophagus Bougie Set is a medical device manufactured by Varian Medical Systems, Inc.. It received FDA 510(k) clearance on 2016-10-02 under approval number K161576. The device is classified under product code JAQ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Esophagus Bougie Set?

Esophagus Bougie Set is a medical device that received FDA 510(k) clearance on 2016-10-02. It is manufactured by Varian Medical Systems, Inc.. The 510(k) number is K161576.

When was Esophagus Bougie Set approved by the FDA?

Esophagus Bougie Set received FDA 510(k) clearance on 2016-10-02, under approval number K161576.

What company makes Esophagus Bougie Set?

Esophagus Bougie Set is manufactured by Varian Medical Systems, Inc..

What is the FDA product code for Esophagus Bougie Set?

The FDA product code for Esophagus Bougie Set is JAQ.

Other Devices by Varian Medical Systems, Inc.

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Related Devices (Code: JAQ)

K160045Heyman Packing Applicator SetVarian Medical Systems, Inc. K161540Advanced Breast Template SystemVarian Medical Systems, Inc. K160516Universal Cylinder Applicator Family, Universal Segmented Cylinder Applicator Set, Universal Stump Applicator Set, Universal Cervix Probe Set, odd lengths, Universal Cervix Probe Set, even lengthsVarian Medical Systems, Inc. K150979CT/MR Compatible M.A.C. Interstitial GYN TemplateMick Radio-Nuclear Instruments, Inc. K160021Varian Sterilization BoxesVarian Medical Systems, Inc. K162533Kelowna GYN and Crook Prostate TemplatesVarian Medical Systems, Inc.

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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