K244029
- 510(k) number
- K244029
- Device name
- ROBOPERA (ER-R-002); ROBOPERA (ER-R-003)
- Applicant
- Endorobotics Co., Ltd. KR
- Product code
- FDF — Colonoscope And Accessories, Flexible/Rigid
- Decision date
- 2025-09-24
- Date received
- 2024-12-30
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 3.4 MB · U.S. public domain
Also available from FDA: K244029.pdf
Official FDA record: K244029
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.