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FDA 510(k)

Catheter Surface Flap Applicator Set (GM11011830)

K-Number: K241965 · 2024-10-29

ApplicantVarian Medical Systems
Decision Date2024-10-29
Product CodeJAQ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Catheter Surface Flap Applicator Set (GM11011830) is the device name listed in this FDA 510(k) record. The listed applicant is Varian Medical Systems. It received FDA 510(k) clearance on 2024-10-29 under 510(k) number K241965. 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 Catheter Surface Flap Applicator Set (GM11011830)?

Catheter Surface Flap Applicator Set (GM11011830) is a medical device that received FDA 510(k) clearance on 2024-10-29. The listed applicant is Varian Medical Systems. The 510(k) number is K241965.

When did Catheter Surface Flap Applicator Set (GM11011830) receive FDA 510(k) clearance?

Catheter Surface Flap Applicator Set (GM11011830) received FDA 510(k) clearance on 2024-10-29, under 510(k) number K241965.

Who is the listed applicant for Catheter Surface Flap Applicator Set (GM11011830)?

The FDA 510(k) record lists Varian Medical Systems as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Catheter Surface Flap Applicator Set (GM11011830)?

The FDA product code for Catheter Surface Flap Applicator Set (GM11011830) is JAQ.

Other records listing Varian Medical Systems 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.

K262383LumenCare AzureNucletron B.V.K252717MAASTRO Rectal Applicator SetVarian Medical SystemsK251037Rectal ApplicatorNucletron B.V.K252884Guided Aarhus Applicator SetVarian Medical SystemsK250299CT/ MR Tandem and Ovoid SetVarian Medical Systems, Inc.K250289Intracavitary/Interstitial SystemVarian Medical Systems

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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