K241213
- 510(k) number
- K241213
- Device name
- PENTAX Medical Video Upper GI Scope (EG27-i20c); PENTAX Medical Video Colonoscope (EC34-i20cL)
- Applicant
- Pentax of America, Inc. NJ · US
- Product code
- FDS — Gastroscope And Accessories, Flexible/Rigid
- Decision date
- 2024-12-06
- Date received
- 2024-04-30
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K241213.pdf
Official FDA record: K241213
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.