Endolumik Fluorescence Guided Gastric Calibration Tube (FG Bougie) (K222880)
Description
Endolumik Fluorescence Guided Gastric Calibration Tube (FG Bougie) by Endolumik, Inc., an FDA 510(k) cleared gastroenterology, urology device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K222880
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. Endolumik Fluorescence Guided Gastric Calibration Tube (FG Bougie) (K222880) cites 1 predicate device and is itself cited by 2 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K130483 | BOEHRINGER GASTRIC SIZING TUBE | Boehringer Laboratories, LLC | 2013 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K240069 | Endolumik Gastric Calibration Tube M Series (EGCT36M); Endo... | Endolumik | 2024 |
| K234145 | ViSiGi 3D Gastric Sizing Tube | Boehringer Laboratories | 2024 |
Trace the full predicate network for K222880
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.