DeviceClearance

Product code KNQ— Gastroenterology, Urology

ACHELASIA BALLOON DIALATOR

Classification name
Dilator, Esophageal
Device class
Class 2
Regulation
21 CFR 876.5365
Advisory panel
Gastroenterology, Urology
Total cleared
40
First cleared
Most recent

Market context for product code KNQ

FDA has cleared 40 devices under product code KNQ between 1981 and 2012, filed by 22 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 KNQ

Adverse events under product code KNQ

product code KNQ
Malfunction
1,844
Total
1,844

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 KNQ

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