FEF

1 FDA 510(k) clearances · Product code

FDA profile

Official device name

Tube, Single Lumen, With Mercury Wt Balloon For Intestinal Intubation And / Or Decompression

Device class

Class II (moderate risk)

Regulation

21 CFR 876.5980

Medical specialty

Gastroenterology, Urology

Flags

Third-party review eligible

Adverse events (MAUDE)

1996: 5 · 1997: 1 · 1998: 2 · 1999: 1 · 2000: 2 · 2001: 1
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.

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