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FDA 510(k)

Flexible Fixation Device for Gynecological Applicators (GM11001960)

K-Number: K240495 · 2024-05-09

ApplicantVarian Medical Systems, Inc.
Decision Date2024-05-09
Product CodeJAQ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Flexible Fixation Device for Gynecological Applicators (GM11001960) is a medical device manufactured by Varian Medical Systems, Inc.. It received FDA 510(k) clearance on 2024-05-09 under approval number K240495. 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 Flexible Fixation Device for Gynecological Applicators (GM11001960)?

Flexible Fixation Device for Gynecological Applicators (GM11001960) is a medical device that received FDA 510(k) clearance on 2024-05-09. It is manufactured by Varian Medical Systems, Inc.. The 510(k) number is K240495.

When was Flexible Fixation Device for Gynecological Applicators (GM11001960) approved by the FDA?

Flexible Fixation Device for Gynecological Applicators (GM11001960) received FDA 510(k) clearance on 2024-05-09, under approval number K240495.

What company makes Flexible Fixation Device for Gynecological Applicators (GM11001960)?

Flexible Fixation Device for Gynecological Applicators (GM11001960) is manufactured by Varian Medical Systems, Inc..

What is the FDA product code for Flexible Fixation Device for Gynecological Applicators (GM11001960)?

The FDA product code for Flexible Fixation Device for Gynecological Applicators (GM11001960) is JAQ.

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Other Devices by Varian Medical Systems, Inc.

K162476Varian High Energy Linear Accelerator K160045Heyman Packing Applicator Set K161540Advanced Breast Template System K161576Esophagus Bougie Set K160516Universal Cylinder Applicator Family, Universal Segmented Cylinder Applicator Set, Universal Stump Applicator Set, Universal Cervix Probe Set, odd lengths, Universal Cervix Probe Set, even lengths K160021Varian Sterilization Boxes

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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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