Data / Medical devices / United States / Endolumik
Endolumik: FDA-registered device maker in Morgantown, WV, United States, 2 510(k) clearances
Endolumik is registered with the FDA (registration 3026671998) in Morgantown, WV, United States. It lists 3 device types. The FDA files 2 510(k) clearances under its listings, the newest dated February 8, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3026671998
- Address
- 364 Patteson Dr. #293, Morgantown, WV, United States, 26505
- Owner or operator
- Endolumik (10087525)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- March 10, 2023
- Registered through
- 2026
- Brand names listed
- CEGCT, Endolumik GCT M Series, Endolumik Gastric Calibration Tube, Endolumik Gastrointestinal Calibration Tube
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Bougie, Esophageal, And Gastrointestinal, Gastro-Urology | FAT | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Bulb, Inflation, For Endoscope | FCY | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Tubes, Gastrointestinal (And Accessories) | KNT | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| February 8, 2024 | K240069 | Endolumik Gastric Calibration Tube M Series (EGCT36M); Endolumik Gastric Calibration Tube M Series (EGCT40M) | KNT | Substantially Equivalent | Endolumik | accessdata.fda.gov |
| March 3, 2023 | K222880 | Endolumik Fluorescence Guided Gastric Calibration Tube (FG Bougie) | KNT | Substantially Equivalent | Endolumik, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Bougie, Esophageal, And Gastrointestinal, Gastro-Urology
- All makers of Bulb, Inflation, For Endoscope
- All makers of Tubes, Gastrointestinal (And Accessories)
Updated February 8, 2024. 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.