FDA product code QTD: Endoscopic Suturing Device For Altering Gastric Anatomy For Weight Loss
QTD is the FDA product code for endoscopic suturing device for altering gastric anatomy for weight loss. It is a Class II device, regulated under 21 CFR 876.5983 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 1 510(k) submission under QTD, 1 in the last five years. The average 510(k) review took 27 days (median 27). 1 De Novo request was granted under it.
Definition
This endoscopic device uses suturing to approximate gastric tissue to restrict the volume of the stomach for the intended purpose of weight loss.
Classification
| Field | Value |
|---|---|
| Device name | Endoscopic Suturing Device For Altering Gastric Anatomy For Weight Loss |
| Device class | Class II |
| Regulation | 21 CFR 876.5983 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
| Implant | Yes |
510(k) clearances per year for QTD
| Year | Clearances | Avg. review days |
|---|---|---|
| 2023 | 1 | 27 |
Compare with all 510(k) review times · Search every QTD clearance
Top QTD applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Apollo Endosurgery, Inc. | 1 | 2023-09-18 |
Most recent QTD clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K232544 | Apollo Endosurgery, Inc. | Apollo ESG NXT System, Apollo REVISE NXT System | 2023-09-18 | 27 |
Recalls for QTD devices
openFDA lists no recalls for product code QTD.
Frequently asked questions
What is FDA product code QTD?
QTD is the FDA product code for endoscopic suturing device for altering gastric anatomy for weight loss. It is a Class II device, regulated under 21 CFR 876.5983 and reviewed by the Gastroenterology and Urology panel.
What device class is QTD?
Class II, regulation 21 CFR 876.5983. Typical premarket route: 510(k).
How long does a 510(k) take for product code QTD?
Across 1 cleared submissions the average was 27 days from receipt to decision (median 27).
Which companies have the most QTD clearances?
Apollo Endosurgery, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code QTD
- Run a recall and safety report across every QTD manufacturer
- Watch product code QTD for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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