Mr. Gan · haixiao@sungolytest.com · +86 158 2169 5110 · +86 132 4819 8029Mr. Luo · jun.luo@sungoglobal.com · +86 177 5560 4650

FCX

Insufflator, Automatic Carbon-Dioxide For Endoscope

Product code
FCX
Device name
Insufflator, Automatic Carbon-Dioxide For Endoscope
Device class
Class 2
21 CFR
21 CFR 876.1500
Medical specialty
Gastroenterology, Urology
Marketing pathway
510(K)
Flag
Third-party review eligible
510(k) clearances (last 3 years)
2
Summaries archived here
2 (direct download)
510(k) clearances (all years, FDA)
25 (all years; only the last 3 years are listed here)

510(k) clearances, last 3 years (2)

Last three years. Most recent: 2026-07-24.

NumberDecision dateApplicantDevice nameSummary
K2621522026-07-24VISION MEDICAL Co., Ltd.VS-370CF, VS-370CTPDF
K2408472024-10-30Ide Vision, Ltd.MedicCO2LON (MedicCO2LON)PDF

2 summaries are archived here for direct download.

Official FDA classification page: FCX
Classification and pathway per current FDA publications. Data from openFDA (CC0).