FDA Product Code QJN: Laparoscopic Accessories, Esophageal Sizing
To Laparoscopically Measure An Extraluminal Dimensional Parameter Of A Gastrointestinal Organ.
Leading manufacturers include Torax Medical, Inc..
2
Total
2
Cleared
54d
Avg days
2020
Since
Declining activity -
0 submissions in the last 2 years
vs 1 in the prior period
FDA 510(k) Cleared Laparoscopic Accessories, Esophageal Sizing Devices (Product Code QJN)
2 devices
About Product Code QJN - Regulatory Context
510(k) Submission Activity
2 total 510(k) submissions under product code QJN since 2020, with 2 receiving FDA clearance (average review time: 54 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.
QJN devices are reviewed by the Gastroenterology & Urology panel. Browse all Gastroenterology & Urology devices →