DeviceClearance

Product code KNT— Gastroenterology, Urology

FLEXIFLO ENTERAL FEEDING TUBE

Classification name
Tubes, Gastrointestinal (And Accessories)
Device class
Class 2
Regulation
21 CFR 876.5980
Advisory panel
Gastroenterology, Urology
Total cleared
651
First cleared
Most recent

Market context for product code KNT

FDA has cleared 651 devices under product code KNT between 1976 and 2026, filed by 275 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

last 15 years

Top applicants under product code KNT

Adverse events under product code KNT

product code KNT
Death
192
Injury
6,034
Malfunction
4,049
Other
1
Total
10,276

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 KNT

1–100 of 651

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