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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 the device name listed in this FDA 510(k) record. The listed applicant is Varian Medical Systems, Inc.. It received FDA 510(k) clearance on 2016-10-02 under 510(k) 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. The listed applicant is Varian Medical Systems, Inc.. The 510(k) number is K161576.

When did Esophagus Bougie Set receive FDA 510(k) clearance?

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

Who is the listed applicant for Esophagus Bougie Set?

The FDA 510(k) record lists Varian Medical Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Esophagus Bougie Set?

The FDA product code for Esophagus Bougie Set is JAQ.

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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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