K251256
- 510(k) number
- K251256
- Device name
- PENTAX Medical Video Upper GI Scopes (EG Family) (EG Family); PENTAX Medical Video Colonoscopes (EC Family) (EC Family)
- Applicant
- Pentax of America, Inc. NJ · US
- Product code
- FDS — Gastroscope And Accessories, Flexible/Rigid
- Decision date
- 2025-12-16
- Date received
- 2025-04-23
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K251256.pdf
Official FDA record: K251256
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.