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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 a medical device manufactured by Varian Medical Systems, Inc.. It received FDA 510(k) clearance on 2017-08-31 under approval 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. It is manufactured by Varian Medical Systems, Inc.. The 510(k) number is K162533.

When was Kelowna GYN and Crook Prostate Templates approved by the FDA?

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

What company makes Kelowna GYN and Crook Prostate Templates?

Kelowna GYN and Crook Prostate Templates is manufactured by Varian Medical Systems, Inc..

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.

Related Clinical Trials

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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. K161576Esophagus Bougie SetVarian 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.

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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