K261587
- 510(k) number
- K261587
- Device name
- Insufflation Retention Device (IRD) (11173-325-101)
- Applicant
- BPEndo, LLC OK · US
- Product code
- FDF — Colonoscope And Accessories, Flexible/Rigid
- Decision date
- 2026-07-02
- Date received
- 2026-05-13
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K261587.pdf
Official FDA record: K261587
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.