Data / Medical devices / Endoscopic Suturing Device For Altering Gastric Anatomy For Weight Loss
Endoscopic Suturing Device For Altering Gastric Anatomy For Weight Loss (QTD): 4 FDA-registered makers in 3 countries
4 establishments in 3 countries are registered with the FDA to make Endoscopic Suturing Device For Altering Gastric Anatomy For Weight Loss (product code QTD, Class 2, 21 CFR 876.5983). 4 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 2 510(k) clearances under this code, the latest on September 18, 2023, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- QTD
- Device class
- 2
- Regulation
- 876.5983
- Medical specialty
- Gastroenterology, Urology
- Implant
- Yes
Makers by country
| Country | Makers |
|---|---|
| United States | 2 |
| Costa Rica | 1 |
| Ireland | 1 |
Makers of Endoscopic Suturing Device For Altering Gastric Anatomy For Weight Loss
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Boston Scientific Corporation | Marlborough, MA, United States | Specification developer | 2 | September 18, 2023 | 0 | 0 | 0 | api.fda.gov |
| Boston Scientific Corporation | El Coyol Alajuela, Costa Rica | Manufacturer | 2 | September 18, 2023 | 0 | 0 | 0 | api.fda.gov |
| Boston Scientific Corporation | Coventry, RI, United States | Manufacturer | 2 | September 18, 2023 | 0 | 0 | 0 | api.fda.gov |
| Boston Scientific Limited | GALWAY Galway(County), Ireland | Manufacturer | 2 | September 18, 2023 | 0 | 0 | 0 | api.fda.gov |
Updated September 18, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.