QTD

Endoscopic Suturing Device For Altering Gastric Anatomy For Weight Loss

Product code
QTD
Device name
Endoscopic Suturing Device For Altering Gastric Anatomy For Weight Loss
Device class
Class 2
21 CFR
21 CFR 876.5983
Medical specialty
Gastroenterology, Urology
Marketing pathway
510(K)
Flag
Implant
510(k) clearances (last 3 years)
1
Summaries archived here
1 (direct download)
510(k) clearances (all years, FDA)
2 (all years; only the last 3 years are listed here)

FDA classification definition

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

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2023-09-18.

NumberDecision dateApplicantDevice nameSummary
K2325442023-09-18Apollo Endosurgery, Inc.Apollo ESG NXT System, Apollo REVISE NXT SystemPDF

1 summaries are archived here for direct download.

Official FDA classification page: QTD
Classification and pathway per current FDA publications. Data from openFDA (CC0).