Data / Medical devices / Tube, Gastro-Enterostomy / United States
FDA-registered makers of Tube, Gastro-Enterostomy in the United States: 10 establishments
10 establishments in the United States are registered with the FDA to make Tube, Gastro-Enterostomy (product code KGC). 7 have a 510(k) clearance or PMA approval on file and 1 has a recall event. FDA data exported November 3, 2026.
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- Device
- Tube, Gastro-Enterostomy
- Product code
- KGC
- Country
- United States
Makers of Tube, Gastro-Enterostomy in the United States
| 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 |
| 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 |
Updated November 3, 2026. 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.