510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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QTDClass II

Endoscopic Suturing Device For Altering Gastric Anatomy For Weight Loss

21 CFR 876.5983 / Gastroenterology, Urology
FDA source (opens on fda.gov)

QTD is the FDA product code for Endoscopic Suturing Device For Altering Gastric Anatomy For Weight Loss, a class II device type, regulated under 21 CFR 876.5983. FDA's definition for this code reads: "This endoscopic device uses suturing to approximate gastric tissue to restrict the volume of the stomach for the intended purpose of weight loss". As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
QTD
Device name
Endoscopic Suturing Device For Altering Gastric Anatomy For Weight Loss
FDA definition
This endoscopic device uses suturing to approximate gastric tissue to restrict the volume of the stomach for the intended purpose of weight loss.
Regulation
21 CFR 876.5983
Device class
Class II
Review panel
Gastroenterology, Urology
Submission type
510(k)
Implant
Yes
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
2
Ingested recalls
0

Clearances, product code QTD

By decision year
2 clearances under product code QTD with a decision year between 2022 and 2023, 2022 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code QTD by decision year
YearClearances
20221
20231

Applicants with the most clearances

Product code QTD
Applicants holding the most 510(k) clearances under product code QTD
ApplicantClearances
Apollo Endosurgery, Inc.2

Companies listing this code with FDA

Companies whose registered establishments list this code