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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Colonoscope And Accessories, Flexible/Rigid
510(k) Number K261587
Device Name Insufflation Retention Device (IRD) (11173-325-101)
Applicant
BPEndo, LLC
1515 N. Porter Ave.
Norman,  OK  73071
Applicant Contact Robert Hollbrook
Correspondent
Gilero, LLC
4319 S. Alston Ave.
Durham,  NC  27713
Correspondent Contact Ann Metz
Regulation Number876.1500
Classification Product Code
FDF  
Date Received05/13/2026
Decision Date 07/02/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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