K242110
- 510(k) number
- K242110
- Device name
- PENTAX Medical Video Colonoscope (EC38-i20cWL)
- Applicant
- Pentax of America, Inc. NJ · US
- Product code
- FDF — Colonoscope And Accessories, Flexible/Rigid
- Decision date
- 2025-01-03
- Date received
- 2024-07-19
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 1.0 MB · U.S. public domain
Also available from FDA: K242110.pdf
Official FDA record: K242110
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.