Data / Medical devices / Bougie, Esophageal, And Gastrointestinal, Gastro-Urology
Bougie, Esophageal, And Gastrointestinal, Gastro-Urology (FAT): 8 FDA-registered makers in 3 countries
8 establishments in 3 countries are registered with the FDA to make Bougie, Esophageal, And Gastrointestinal, Gastro-Urology (product code FAT, Class 2, 21 CFR 876.5365). 3 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 8 510(k) clearances under this code, the latest on June 16, 2014, and lists 2 recall events (0 Class I). FDA data exported November 3, 2026.
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- Product code
- FAT
- Device class
- 2
- Regulation
- 876.5365
- Medical specialty
- Gastroenterology, Urology
Makers by country
| Country | Makers |
|---|---|
| United States | 4 |
| China | 3 |
| Australia | 1 |
Makers of Bougie, Esophageal, And Gastrointestinal, Gastro-Urology
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 |
|---|---|---|---|---|---|---|---|---|
| Diversatek Healthcare Inc | Milwaukee, WI, United States | Contract manufacturer, Manufacturer | 1 | February 2, 1998 | 0 | 0 | 0 | api.fda.gov |
| Teleflex LLC (NADC) | Olive Branch, MS, United States | Manufacturer, Repackager or relabeler | 1 | June 16, 2014 | 0 | 0 | 0 | api.fda.gov |
| Teleflex Medical LLC | Morrisville, NC, United States | Complaint file establishment, Specification developer | 1 | June 16, 2014 | 0 | 0 | 0 | api.fda.gov |
| Changzhou Intl. Trade & Enterprises Cooperative Co., Ltd. | changzhou Jiangsu, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Changzhou Jiuhong Medical Instrument Co., Ltd. | CHANGZHOU Jiangsu, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Endolumik | Morgantown, WV, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Inka Surgical Instruments | Jandakot Western Australia, Australia | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jiangsu Vedkang Medical Science and Technology Co.,Ltd. | Changzhou Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated June 16, 2014. 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.