DeviceClearance

Product code QTD— Gastroenterology, Urology

APOLLO ESG System, APOLLO ESG SX System, APOLLO REVISE System, APOLLO REVISE SX System

Classification name
Endoscopic Suturing Device For Altering Gastric Anatomy For Weight Loss
Device class
Class 2
Regulation
21 CFR 876.5983
Advisory panel
Gastroenterology, Urology
Total cleared
2
First cleared
Most recent

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.”

— U.S. Food and Drug Administration, device classification record for product code QTD under 21 CFR 876.5983, via openFDA

Market context for product code QTD

FDA has cleared 2 devices under product code QTD between 2022 and 2023, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code QTD

Recent clearances under product code QTD

Data sourced from openFDA. This site is unofficial and independent of the FDA.