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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 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 2024-04-09 under 510(k) 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. The listed applicant is Varian Medical Systems, Inc.. The 510(k) number is K232623.

When did Universal Endometrial Applicator Set (GM11009840) receive FDA 510(k) clearance?

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

Who is the listed applicant for Universal Endometrial Applicator Set (GM11009840)?

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 Universal Endometrial Applicator Set (GM11009840)?

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

Other records listing Varian Medical Systems, Inc. as applicant

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Related Devices (Code: JAQ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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