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Esophageal Dilator Balloon With Or Without Electrode Sensors

FDA product code PID · Class 2 · Gastroenterology, Urology

7
Registered devices
143
Adverse events
1
Recalls
3
510(k) clearances

Devices with this code

Cook — COOK INCORPORATEDEsoFLIP — Covidien LPRIGIFLEX II — BOSTON SCIENTIFIC CORPORATIONRIGIFLEX II — BOSTON SCIENTIFIC CORPORATIONCook — COOK INCORPORATEDEsoFLIP — Covidien LPRIGIFLEX II — BOSTON SCIENTIFIC CORPORATION

Recent recalls

DateFirmReason
2024-04-25Covidien, LLCDue to saline conductivity issues, their is a potential that dilation catheters may provide inaccurate esophageal diameter measurements that may lead to variou

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.