K262152
- 510(k) number
- K262152
- Device name
- VS-370CF, VS-370CT
- Applicant
- VISION MEDICAL Co., Ltd. KR
- Product code
- FCX — Insufflator, Automatic Carbon-Dioxide For Endoscope
- Decision date
- 2026-07-24
- Date received
- 2026-06-25
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Flag
- Third-party review
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 0.9 MB · U.S. public domain
Also available from FDA: K262152.pdf
Official FDA record: K262152
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.