DeviceClearance

Product code FEG— Gastroenterology, Urology

14Fr Colon Decompression Set, Macon Colon Decompression Set

Classification name
Tube, Double Lumen For Intestinal Decompression And/Or Intubation
Device class
Class 2
Regulation
21 CFR 876.5980
Advisory panel
Gastroenterology, Urology
Total cleared
13
First cleared
Most recent

Market context for product code FEG

FDA has cleared 13 devices under product code FEG between 1977 and 2017, filed by 12 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code FEG

Adverse events under product code FEG

product code FEG
Death
2
Total
2

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recent clearances under product code FEG

Data sourced from openFDA. This site is unofficial and independent of the FDA.