FDA Product Code QTD: Endoscopic Suturing Device For Altering Gastric Anatomy For Weight Loss
This Endoscopic Device Uses Suturing To Approximate Gastric Tissue To Restrict The Volume Of The Stomach For The Intended Purpose Of Weight Loss.
Leading manufacturers include Apollo Endosurgery, Inc..
2
Total
1
Cleared
156d
Avg days
2022
Since
Declining activity -
0 submissions in the last 2 years
vs 2 in the prior period
FDA 510(k) Cleared Endoscopic Suturing Device For Altering Gastric Anatomy For Weight Loss Devices (Product Code QTD)
2 devices
Cleared
Sep 18, 2023
Apollo ESG NXT System, Apollo REVISE NXT System
Apollo Endosurgery, Inc.
Gastroenterology & Urology
27d
Not Cleared
Jul 12, 2022
APOLLO ESG System, APOLLO ESG SX System, APOLLO REVISE System, APOLLO REVISE SX System
Apollo Endosurgery, Inc.
Gastroenterology & Urology
285d
About Product Code QTD - Regulatory Context
510(k) Submission Activity
2 total 510(k) submissions under product code QTD since 2022, with 1 receiving FDA clearance (average review time: 156 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 2 in the prior period.
QTD devices are reviewed by the Gastroenterology & Urology panel. Browse all Gastroenterology & Urology devices →