Irrigation/Urology Sets
FDA 510(k) K254111 · B.Braun Medical, Inc.
510(k) numberK254111
Submission
- Device name
- Irrigation/Urology Sets
- Applicant
- B.Braun Medical, Inc.
Center Valley, PA, US - Received
- December 19, 2025
- Decision date
- September 10, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LJH – System, Irrigation, Urological
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5130
- Specialty
- Gastroenterology, Urology
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| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K162992 | Karl Storz UROMAT E.A.S.I.LJH · Traditional | Karl Storz Endoscopy America, Inc. | 07/07/2017SE |
| K070873 | Amsure Bladder Irrigation SetLJH · Traditional | Amsino Intl., Inc. | 12/19/2007SE |
| K071832 | Modifcation to: Spyglass Irrigation SystemLJH · Special | Medical Scientific, Inc. | 09/18/2007SE |
| K063700 | Spyglass Irrigation SystemLJH · Traditional | Medical Scientific, Inc. | 02/08/2007SE |
| K062551 | Nexus Irrigation Tubing SetLJH · Traditional | Nexus Medical, LLC | 12/15/2006SE |
| K042457 | Uro ProLJH · Traditional | W.O.M. World of Medicine AG | 10/25/2004SE |
| K040094 | Piggyback Irrigating SystemLJH · Abbreviated | Kosin Technologies, LLC | 04/15/2004SE |
| K023808 | Irrigation SetsLJH · Traditional | International Medsurg Connection | 03/10/2003SE |
| K010607 | Med-Rx Irrigation Set, Model 10-3001, 10-3002, 10-4000, 10-4001LJH · Traditional | Benlan, Inc. | 11/28/2001SE |
| K010122 | Continuous Flow Y-TubingLJH · Traditional | G.U.-Tek | 06/04/2001SE |
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Questions and answers
When was Irrigation/Urology Sets cleared by the FDA?
Irrigation/Urology Sets (K254111) received a 510(k) decision of Substantially Equivalent on September 10, 2026, 265 days after the submission was received.
What is the product code of K254111?
The FDA product code is LJH – System, Irrigation, Urological, a Class II (moderate risk) device regulated under 21 CFR 876.5130.