QJN — Laparoscopic Accessories, Esophageal Sizing Class II

FDA Device Classification

Classification Details

Product Code
QJN
Device Class
Class II
Regulation Number
876.5360
Submission Type
Review Panel
GU
Medical Specialty
Gastroenterology, Urology
Implant
No

Definition

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

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K230089torax medicalETHICON LINX® Esophagus Sizing ToolFebruary 9, 2023
K201035torax medicalETHICON Linx Esophagus Sizing ToolJuly 9, 2020