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FDA 510(k)

Kelowna GYN and Crook Prostate Templates

K-Number: K162533 · 2017-08-31

ApplicantVarian Medical Systems, Inc.
Decision Date2017-08-31
Product CodeJAQ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Kelowna GYN and Crook Prostate Templates 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 2017-08-31 under 510(k) number K162533. 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 Kelowna GYN and Crook Prostate Templates?

Kelowna GYN and Crook Prostate Templates is a medical device that received FDA 510(k) clearance on 2017-08-31. The listed applicant is Varian Medical Systems, Inc.. The 510(k) number is K162533.

When did Kelowna GYN and Crook Prostate Templates receive FDA 510(k) clearance?

Kelowna GYN and Crook Prostate Templates received FDA 510(k) clearance on 2017-08-31, under 510(k) number K162533.

Who is the listed applicant for Kelowna GYN and Crook Prostate Templates?

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 Kelowna GYN and Crook Prostate Templates?

The FDA product code for Kelowna GYN and Crook Prostate Templates 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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