K232249
- 510(k) number
- K232249
- Device name
- PENTAX Medical Gas/Water Feeding Valve OE-B14
- Applicant
- Pentax of America, Inc. NJ · US
- Product code
- ODC — Endoscope Channel Accessory
- Decision date
- 2023-12-01
- Date received
- 2023-07-28
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 2.8 MB · U.S. public domain
Also available from FDA: K232249.pdf
Official FDA record: K232249
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.