DeviceClearance

Product code QJN— Gastroenterology, Urology

ETHICON LINX® Esophagus Sizing Tool

Classification name
Laparoscopic Accessories, Esophageal Sizing
Device class
Class 2
Regulation
21 CFR 876.5360
Advisory panel
Gastroenterology, Urology
Total cleared
2
First cleared
Most recent

FDA classification definition

“To laparoscopically measure an extraluminal dimensional parameter of a gastrointestinal organ.”

— U.S. Food and Drug Administration, device classification record for product code QJN under 21 CFR 876.5360, via openFDA

Market context for product code QJN

FDA has cleared 2 devices under product code QJN between 2020 and 2023, filed by 1 applicant company. 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 QJN

Recent clearances under product code QJN

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