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FDA approves Cordis Selution SLR, the first sirolimus drug-eluting balloon sold in the US FDA panel takes up GRAIL's Galleri cancer screening PMA on September 23 FDA folds the human factors guidance into eSTAR 7.1 and widens PreSTAR to five more meeting types AVAVA raises $45M with a third of it in debt from its lead investor UpFront Diagnostics wins a CE mark for a 10-minute stroke blood test Ambu pays $45M upfront for TIMS Medical and about 7,000 US hospital installs Citi downgrades Boston Scientific over the cyberattack recovery Autonomix puts Medtronic's former chief regulatory counsel on its board FDA calls the NOxBOXi oxygen leak fix a Class II correction, three years after a Class I recall FDA approves Cordis Selution SLR, the first sirolimus drug-eluting balloon sold in the US FDA panel takes up GRAIL's Galleri cancer screening PMA on September 23 FDA folds the human factors guidance into eSTAR 7.1 and widens PreSTAR to five more meeting types AVAVA raises $45M with a third of it in debt from its lead investor UpFront Diagnostics wins a CE mark for a 10-minute stroke blood test Ambu pays $45M upfront for TIMS Medical and about 7,000 US hospital installs Citi downgrades Boston Scientific over the cyberattack recovery Autonomix puts Medtronic's former chief regulatory counsel on its board FDA calls the NOxBOXi oxygen leak fix a Class II correction, three years after a Class I recall

The Tracker / September 2026 / K254111

510(k) cleared

Irrigation/Urology Sets

B.Braun Medical, Inc. · Sep 10, 2026 · K254111

FDA cleared the Irrigation/Urology Sets from B.Braun Medical, Inc. on Sep 10, 2026 under K254111, a traditional 510(k). The device falls under product code LJH, System, Irrigation, Urological, regulated at 21 CFR 876.5130 as a Class 2 device. The review panel was Gastroenterology, Urology.

FDA logged the submission as received on Dec 19, 2025. The decision came 265 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

B.Braun Medical, Inc. has one other decision in the tracker over the last 12 months: K253235 (Introcan Safety® Deep Access XL IV Catheter).

Questions & Answers

What did FDA clear under K254111?

K254111 is the FDA 510(k) for Irrigation/Urology Sets, submitted by B.Braun Medical, Inc.. FDA's decision date was Sep 10, 2026, under product code LJH (System, Irrigation, Urological).

Who makes the Irrigation/Urology Sets?

B.Braun Medical, Inc., based in Center Valley, PA, is the applicant of record for K254111.

How long did the K254111 review take?

FDA received the submission on Dec 19, 2025 and issued its decision on Sep 10, 2026, 265 days later.

← All decisions in September 2026

Sources