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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Straight
510(k) Number K263512
Device Name Luja female
Applicant
Coloplast Corp.
1601 W. River Rd. N
Minneapolis,  MN  55411
Applicant Contact Vallabha Tantry
Correspondent
Coloplast Corp.
1601 W. River Rd. N
Minneapolis,  MN  55411
Correspondent Contact Vallabha Tantry
Regulation Number876.5130
Classification Product Code
EZD  
Date Received09/29/2026
Decision Date 10/28/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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