Luer-Split MAJ-2092
FDA 510(k) K241842 · Olympus Medical Systems Corporation
510(k) numberK241842
Submission
- Device name
- Luer-Split MAJ-2092
- Applicant
- Olympus Medical Systems Corporation
Hachioji-Shi, JP - Received
- June 26, 2024
- Decision date
- March 19, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- ODC – Endoscope Channel Accessory
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
To give the endoscope channel additional or improved functionality.
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|---|---|---|---|
| K252933 | Dyne PortODC · Traditional | Dyne Medical Group, Inc. | 06/12/2026SE |
| K250145 | Biopsy Port AdapterODC · Traditional | Endosound, Inc. | 10/17/2025SE |
| K252910 | Orca Air/Water and Suction ValvesODC · Special | Boston Scientific | 10/09/2025SESK |
| K250949 | Suction Valve (MAJ-1443); Air/Water Valve (MAJ-1444)ODC · Traditional | Olympus Medical Systems Corporation | 07/16/2025SE |
| K250732 | Disposable Endoscopy Valve SetODC · Traditional | Yangzhou Fartley Medical Instrument Technology… | 06/20/2025SE |
| K250140 | Defendo Fujifilm 700 Single Use Cleaning AdapterODC · Special | Steris Corparation | 02/20/2025SE |
| K243075 | Defendo Single Use Cleaning Adapter for Olympus Endoscopes (100322, 100323, 4000096…ODC · Special | STERIS Corporation | 11/08/2024SE |
| K242742 | DEFENDO Single Use Valve Kit AW/S Valves - 2pc for OLYMPUS EUS (00711900)ODC · Special | STERIS Corporation | 10/11/2024SE |
| K241285 | Disposable Endoscope Valves Set (AF series)ODC · Traditional | Alton (Shanghai) Medical Instruments Co., Ltd. | 10/01/2024SE |
| K232067 | Defendo Fujifilm 500/600 Single Use Air/Water Valve, Defendo Fujifilm 500/600 Single Use…ODC · Traditional | Medivators (A Subsidiary of Steris Corporation) | 03/22/2024SE |
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| K260401 | Evis Eus Ultrasound Bronchofibervideoscope Olympus BF-UCP190F (BF-UCP190F)PSV · Traditional | 08/27/2026SE |
| K261183 | EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190)ODG · Traditional | 07/31/2026SE |
| K254056 | THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S (TB-0545FCS); THUNDERBEAT 5 mm, 35…GEI · Traditional | 07/01/2026SE |
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| K260580 | Single Use Reloadable Clip Applicator (HX-810LR, HX-810UR); Clip (HX-610-090…PKL · Traditional | 05/21/2026SE |
| K252341 | Evis Exera III Bronchovideoscope (Olympus BF-Q190); Evis Exera III Bronchovideoscope…EOQ · Traditional | 04/23/2026SE |
| K252050 | Disposable Biopsy Forceps FB-211D, FB-221D, FB-231D, FB-241DEOB · Traditional | 03/20/2026SE |
Questions and answers
When was Luer-Split MAJ-2092 cleared by the FDA?
Luer-Split MAJ-2092 (K241842) received a 510(k) decision of Substantially Equivalent on March 19, 2025, 266 days after the submission was received.
What is the product code of K241842?
The FDA product code is ODC – Endoscope Channel Accessory, a Class II (moderate risk) device regulated under 21 CFR 876.1500.