QTD — Endoscopic Suturing Device For Altering Gastric Anatomy For Weight Loss Class II

FDA Device Classification

Classification Details

Product Code
QTD
Device Class
Class II
Regulation Number
876.5983
Submission Type
Review Panel
GU
Medical Specialty
Gastroenterology, Urology
Implant
Yes

Definition

This endoscopic device uses suturing to approximate gastric tissue to restrict the volume of the stomach for the intended purpose of weight loss.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K232544apollo endosurgeryApollo ESG NXT System, Apollo REVISE NXT SystemSeptember 18, 2023
DEN210045apollo endosurgeryAPOLLO ESG System, APOLLO ESG SX System, APOLLO REVISE System, APOLLO REVISE SX July 12, 2022