Data / Medical devices / Tube, Gastro-Enterostomy
Tube, Gastro-Enterostomy (KGC): 12 FDA-registered makers in 2 countries
12 establishments in 2 countries are registered with the FDA to make Tube, Gastro-Enterostomy (product code KGC, Class 2, 21 CFR 876.5980). 8 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 26 510(k) clearances under this code, the latest on April 29, 2025, and lists 5 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- KGC
- Device class
- 2
- Regulation
- 876.5980
- Medical specialty
- Gastroenterology, Urology
Makers by country
| Country | Makers |
|---|---|
| United States | 10 |
| Mexico | 2 |
Makers of Tube, Gastro-Enterostomy
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 |
|---|---|---|---|---|---|---|---|---|
| Applied Medical Technology, Inc. | Brecksville, OH, United States | Manufacturer | 2 | March 12, 2020 | 0 | 0 | 0 | api.fda.gov |
| AVENT S. de R.L. de C.V. | NOGALES Sonora, Mexico | Manufacturer, Repackager or relabeler | 2 | December 8, 2009 | 0 | 0 | 0 | api.fda.gov |
| Avanos Medical, Inc. | Alpharetta, GA, United States | Specification developer | 2 | December 8, 2009 | 0 | 0 | 0 | api.fda.gov |
| CoapTech, Inc. | Baltimore, MD, United States | Complaint file establishment, Manufacturer, Repackager or relabeler | 2 | April 29, 2025 | 0 | 0 | 0 | api.fda.gov |
| Cook Incorporated | Bloomington, IN, United States | Complaint file establishment, Manufacturer | 2 | June 26, 2019 | 0 | 0 | 0 | api.fda.gov |
| Argon Medical Devices Inc. | Athens, TX, United States | Manufacturer, Repackager or relabeler | 1 | October 24, 1978 | 0 | 1 | 0 | api.fda.gov |
| MEDLINE INDUSTRIES, LP - Northfield | Northfield, IL, United States | Specification developer | 1 | March 19, 2008 | 0 | 0 | 0 | api.fda.gov |
| Trident Manufacturing, Inc. | Pingree Grove, IL, United States | Contract manufacturer, Repackager or relabeler | 1 | December 8, 2009 | 0 | 0 | 0 | api.fda.gov |
| Life Science Outsourcing, Inc. | Brea, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| LaunchPort LLC | Baltimore, MD, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Martech Medical Products | Harleysville, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Martech Medical Products S. De RL. De CV. | MEXICALI Baja California, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated April 29, 2025. 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.