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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 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 2024-05-09 under 510(k) 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. The listed applicant is Varian Medical Systems, Inc.. The 510(k) number is K240495.

When did Flexible Fixation Device for Gynecological Applicators (GM11001960) receive FDA 510(k) clearance?

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

Who is the listed applicant for Flexible Fixation Device for Gynecological Applicators (GM11001960)?

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 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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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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