Atlas FDA

Luer-Split MAJ-2092

FDA 510(k) clearance K241842 · decided 2025-03-19

Clearance details

K-number
K241842
Device name
Luer-Split MAJ-2092
Applicant
Olympus Medical Systems Corporation
Decision
Substantially Equivalent
Date received
2024-06-26
Decision date
2025-03-19
Days to decision
266 days
Clearance type
Traditional
Product code
ODC
Device class
2
Regulation number
876.1500
Medical specialty
Gastroenterology, Urology
Advisory committee
Gastroenterology, Urology
Location
Hachioji-Shi, JP
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.