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FDA 510(k)

Titanium Flexible Geometry FSD Applicator Set (GM11013400)

K-Number: K243939 · 2025-03-03

Decision Date2025-03-03
Product CodeJAQ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Titanium Flexible Geometry FSD Applicator Set (GM11013400) 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 2025-03-03 under 510(k) number K243939. 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 Titanium Flexible Geometry FSD Applicator Set (GM11013400)?

Titanium Flexible Geometry FSD Applicator Set (GM11013400) is a medical device that received FDA 510(k) clearance on 2025-03-03. The listed applicant is Varian Medical Systems, Inc.. The 510(k) number is K243939.

When did Titanium Flexible Geometry FSD Applicator Set (GM11013400) receive FDA 510(k) clearance?

Titanium Flexible Geometry FSD Applicator Set (GM11013400) received FDA 510(k) clearance on 2025-03-03, under 510(k) number K243939.

Who is the listed applicant for Titanium Flexible Geometry FSD Applicator Set (GM11013400)?

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 Titanium Flexible Geometry FSD Applicator Set (GM11013400)?

The FDA product code for Titanium Flexible Geometry FSD Applicator Set (GM11013400) is JAQ.

Other records listing Varian Medical Systems, Inc. as applicant

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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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.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.