K240069
- 510(k) number
- K240069
- Device name
- Endolumik Gastric Calibration Tube M Series (EGCT36M); Endolumik Gastric Calibration Tube M Series (EGCT40M)
- Applicant
- Endolumik WV · US
- Product code
- KNT — Tubes, Gastrointestinal (And Accessories)
- Decision date
- 2024-02-08
- Date received
- 2024-01-09
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K240069.pdf
Official FDA record: K240069
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.