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FDA 510(k)

Irrigation/Urology Sets

K-Number: K254111 · 2026-09-10

ApplicantB.Braun Medical, Inc.
Decision Date2026-09-10
Product CodeLJH
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Irrigation/Urology Sets is the device name listed in this FDA 510(k) record. The listed applicant is B.Braun Medical, Inc.. It received FDA 510(k) clearance on 2026-09-10 under 510(k) number K254111. The device is classified under product code LJH. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Irrigation/Urology Sets?

Irrigation/Urology Sets is a medical device that received FDA 510(k) clearance on 2026-09-10. The listed applicant is B.Braun Medical, Inc.. The 510(k) number is K254111.

When did Irrigation/Urology Sets receive FDA 510(k) clearance?

Irrigation/Urology Sets received FDA 510(k) clearance on 2026-09-10, under 510(k) number K254111.

Who is the listed applicant for Irrigation/Urology Sets?

The FDA 510(k) record lists B.Braun Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Irrigation/Urology Sets?

The FDA product code for Irrigation/Urology Sets is LJH.

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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.

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