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FDA 510(k)

Universal Endometrial Applicator Set (GM11009840)

K-Number: K232623 · 2024-04-09

ApplicantVarian Medical Systems, Inc.
Decision Date2024-04-09
Product CodeJAQ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Universal Endometrial Applicator Set (GM11009840) is a medical device manufactured by Varian Medical Systems, Inc.. It received FDA 510(k) clearance on 2024-04-09 under approval number K232623. 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 Universal Endometrial Applicator Set (GM11009840)?

Universal Endometrial Applicator Set (GM11009840) is a medical device that received FDA 510(k) clearance on 2024-04-09. It is manufactured by Varian Medical Systems, Inc.. The 510(k) number is K232623.

When was Universal Endometrial Applicator Set (GM11009840) approved by the FDA?

Universal Endometrial Applicator Set (GM11009840) received FDA 510(k) clearance on 2024-04-09, under approval number K232623.

What company makes Universal Endometrial Applicator Set (GM11009840)?

Universal Endometrial Applicator Set (GM11009840) is manufactured by Varian Medical Systems, Inc..

What is the FDA product code for Universal Endometrial Applicator Set (GM11009840)?

The FDA product code for Universal Endometrial Applicator Set (GM11009840) 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. 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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